• Prescribing Info Main
• Derma-Smoothe/FS® Scalp Oil
• Derma-Smoothe/FS® Body Oil
• DermOtic® Oil Ear Drops
• Non-Prescription Products

Prescribing information for DERMA-SMOOTHE/FS®

DERMA-SMOOTHE/FS®
fluocinolone acetonide Topical Oil, 0.01%
(BODY OIL)
NDC 28105-150-04
For Topical Use Only
Not for Oral, Ophthalmic, or Intravaginal Use

HIGHLIGHTS OF THE PRESCRIBING INFORMATION

These highlights do not include all the information needed to
use Derma-Smoothe/FS® safely and effectively. See full
prescribing information for Derma-Smoothe/FS®.

Derma-Smoothe/FS® (fluocinolone acetonide) Topical Oil,
0.01% (Body Oil)
For topical use only
Initial U.S. Approval: 1988

RECENT MAJOR CHANGES

Indication and Usage, Pediatric Patients with Atopic Dermatitis
(1.2) 11/2007

INDICATION AND USAGE

Derma-Smoothe/FS® is a corticosteroid indicated for the
• topical treatment of atopic dermatitis in adult patients
(1.1)
• topical treatment of moderate to severe atopic dermatitis
in pediatric patients 3 months and older for up to 4 weeks
(1.2)
Limitations of Use:
• Apply the least amount to cover affected areas.
Discontinue when disease is controlled. (1.3)
• Do not use in the diaper area. (1.3)
• Do not use on the face, axillae, or groin. (1.3, 6.2, 8.4)

DOSAGE AND ADMINISTRATION

Derma-Smoothe/FS® is not for oral, ophthalmic, or intravaginal
use.(2)
• Adult patients: Apply to affected areas 3 times daily.
(2.1)
• Pediatric patients: Moisten skin and apply to affected
areas twice daily for up to 4 weeks. (2.2)

DOSAGE FORM AND STRENGTHS

Derma-Smoothe/FS® (fluocinolone acetonide) Topical Oil,0.01%
(Body Oil) is supplied in bottles containing 4 fluid ounces. (3)

CONTRAINDICATIONS

None (4).

WARNINGS AND PRECAUTIONS

Topical corticosteroids can produce reversible HPA axis
suppression, Cushing's syndrome, hyperglycemia, and
glucosuria. (5.1)
• Systemic absorption may require evaluation for hypothalamic-
pituitary-adrenal (HPA) axis suppression. (5.1)
• Modify use should HPA axis suppression develop. (5.1)
• Potent corticosteroids, use on large areas, prolonged use
or occlusive use may increase systemic absorption. (5.1)
• Local adverse reactions may include atrophy, striae
irritation, acneiform eruptions, hypopigmentation, and
allergic contact dermatitis and may be more likely with
occlusive use or more potent corticosteroids (5.2,5.3,6.1)
• Children may be more susceptible to systemic toxicity
from equivalent doses. (5.1,8.4)

ADVERSE REACTIONS

The most common adverse reactions (≥ 5%) were cough (20%),
rhinorrhea (13%), pyrexia (10% ), telangiectasia (7%),
nasopharyngitis (7%), and hypopigmentation (7%).

To report SUSPECTED ADVERSE REACTIONS, contact Hill
Dermaceuticals, Inc. at 1-800-344-5707 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and
FDA-approved patient labeling.

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATION AND USAGE

• 1.1 Adult Patients with Atopic Dermatitis
• 1.2 Pediatric Patients with Atopic Dermatitis
• 1.3 Limitations of Use

2 DOSAGE AND ADMINISTRATION

• 2.1 Adult Patients with Atopic Dermatitis
• 2.2 Pediatric Patients with Atopic Dermatitis

3 DOSAGE FORM AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

• 5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression
  
• 5.2 Local Adverse Reactions with Topical Corticosteroids
  
• 5.3 Allergic Contact Dermatitis with Topical Corticosteroids
  
• 5.4 Concomitant Skin Infections
  
• 5.5 Use in Peanut-Sensitive Individuals

6 ADVERSE REACTIONS

• 6.1 Clinical Studies Experience: Evaluation of Facial Use in
  Pediatric Subjects
  
• 6.2 Clinical Studies Experience: Evaluation in Pediatric
  Subjects 3 months to 2 years old
  

8 USE IN SPECIFIC POPULATIONS

• 8.1 Pregnancy
  
• 8.3 Nursing Mothers
  
• 8.4 Pediatric Use
  

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

• 12.1 Mechanism of Action
  
• 12.3 Pharmacokinetics
  

13 NONCLINICAL TOXICOLOGY

• 13.1 Carcinogenesis, mutagenesis, impairment of fertility
  

16 HOW SUPPLIED / STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

• 17.1 Instructions

* Sections or subsections omitted from the Full Prescribing Information are not listed.

FULL PRESCRIBING INFORMATION

1.1 Adult Patients with Atopic Dermatitis
Derma-Smoothe/FS® is indicated for the topical
treatment of atopic dermatitis in adult patients.

1.2 Pediatric Patients with Atopic Dermatitis
Derma-Smoothe/FS® is indicated for the topical
treatment of moderate to severe atopic dermatitis in
pediatric patients, 3 months and older for up to 4 weeks.
Safety and effectiveness in pediatric patients younger than
3 months of age have not been established.

1.3 Limitations of Use
Apply the least amount of Derma-Smoothe/FS®
needed to cover the affected areas. As with other
corticosteroids, Derma-Smoothe/FS® should be
discontinued when control of disease is achieved. Contact
the physician if no improvement is seen within 2 weeks.
Derma-Smoothe/FS should not be applied to the
diaper area; diapers or plastic pants may constitute
occlusive use.
Derma-Smoothe/FS should not be used on the face,
axillae, or groin unless directed by the physician.
Application to intertriginous areas should be avoided due to
the increased risk of local adverse reactions. [see Adverse
Reactions (6) and Use in Specific Populations (8.4)].

2 DOSAGE AND ADMINISTRATION

Derma-Smoothe/FS is not for oral, ophthalmic, or
intravaginal use.

The dosing of Derma-Smoothe/FS is different for
adult and pediatric patients.

2.1 Adult Patients with Atopic Dermatitis
Apply Derma-Smoothe/FS as a thin film to the
affected areas three times daily.

2.2 Pediatric Patients with Atopic Dermatitis
Moisten skin and apply Derma-Smoothe/FS as a thin
film to the affected areas twice daily for up to four weeks.

3 DOSAGE FORMS AND STRENGTHS
Derma-Smoothe/FS® (fluocinolone acetonide),
Topical Oil, 0.01% (Body Oil) is supplied in bottles
containing 4 fluid ounces.

4 CONTRAINDICATIONS
None

5 WARNINGS AND PRECAUTIONS

5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression
Systemic absorption of topical corticosteroids can
produce reversible hypothalamic-pituitary-adrenal (HPA)
axis suppression with the potential for glucocorticosteroid
insufficiency. Cushing's syndrome, hyperglycemia, and
glucosuria can also be produced by systemic absorption of
topical corticosteroids.

Because of the potential for systemic absorption, use
of topical corticosteroids may require that patients be
periodically evaluated for HPA axis suppression. The
ACTH stimulation test may be helpful in evaluating
patients for HPA axis suppression.

If HPA axis suppression is documented, an attempt
should be made to withdraw the drug, to reduce the
frequency of application, or to substitute a less potent
corticosteroid. Recovery of HPA axis function is generally
prompt upon discontinuation of topical corticosteroids.

Conditions which increase systemic absorption
include the use of more potent corticosteroids, use over
large surface areas, use over prolonged periods, and use of
occlusive dressings. Manifestations of adrenal
insufficiency may require supplemental systemic
corticosteroids.

Children may be more susceptible to systemic toxicity
from equivalent doses due to their larger skin surface to
body mass ratios. [See Use in Specific Populations (8.4)]

5.2 Local Adverse Reactions with Topical Corticosteroids
Local adverse reactions may occur with use of topical
corticosteroids and may be more likely to occur with
occlusive use, prolonged use or use of higher potency
corticosteroids. Some local adverse reactions may be
irreversible. Reactions may include atrophy, striae,
telangiectasias, burning, itching, irritation, dryness,
folliculitis, acneiform eruptions, hypopigmentation,
perioral dermatitis, allergic contact dermatitis, secondary
infection, and miliaria. [See Adverse Reactions (6.1)]

5.3 Allergic Contact Dermatitis with Topical Corticosteroids
Allergic contact dermatitis to any component of
topical corticosteroids is usually diagnosed by a failure to
heal rather than a clinical exacerbation. Clinical diagnosis
of allergic contact dermatitis can be confirmed by patch
testing.

5.4 Concomitant Skin Infections
Concomitant skin infections should be treated with an
appropriate antimicrobial agent. If the infection persists
unchanged, Derma-Smoothe/FS® should be discontinued
until the infection has been adequately treated.

5.5 Use in Peanut-Sensitive Individuals
Physicians should use caution in prescribing Derma-Smoothe/FS for peanut-sensitive individuals. [See Description (11)]
Should signs of hypersensitivity present (wheal and
flare reactions, pruritus, or other manifestations), or should
disease exacerbations occur, Derma-Smoothe/FS should be
discontinued immediately and appropriate therapy
instituted.

6 ADVERSE REACTIONS
Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the
clinical trials of a drug cannot be directly compared to rates
in the clinical trials of another drug and may not reflect the
rates observed in practice.

6.1 Clinical Studies Experience: Evaluation of
Facial Use in Pediatric Subjects
An, open-label, study was conducted in 58 children
with moderate to severe atopic dermatitis (2 to 12 years
old) to evaluate the safety of Derma-Smoothe/FS® when
applied to the face twice daily for 4 weeks. The following
adverse reactions were reported:

*The number of individual adverse reactions reported
does not necessarily reflect the number of individual
subjects, since one subject could have multiple reporting of
an adverse reaction.
**End of Treatment
***Four Weeks Post Treatment

6.2 Clinical Studies Experience: Evaluation in
Pediatric Subjects 3 months to 2 years old
An open-label safety study was conducted in 29
children to assess the HPA axis by ACTH stimulation
testing following use of Derma-Smoothe/FS twice daily for
4 weeks. The following adverse reactions were reported in
the study [See Use in Specific Populations (8.4)]:

*Includes one subject who withdrew at Week 2

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
Pregnancy Category C: Corticosteroids have been
shown to be teratogenic in laboratory animals when
administered systemically at relatively low dosage levels.
Some corticosteroids have been shown to be teratogenic
after dermal application in laboratory animals.

There are no adequate and well-controlled studies in
pregnant women on teratogenic effects from Derma-
Smoothe/FS. Therefore, Derma-Smoothe/FS should be
used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.

8.3 Nursing Mothers
Systemically administered corticosteroids appear in
human milk and could suppress growth, interfere with
endogenous corticosteroid production, or cause other
untoward effects. It is not known whether topical
administration of corticosteroids could result in sufficient
systemic absorption to produce detectable quantities in
human milk. Because many drugs are excreted in human
milk, caution should be exercised when Derma-
Smoothe/FS is administered to a nursing woman.

8.4 Pediatric Use

8.4.1 Systemic Adverse Reactions in Pediatric
Patients
HPA axis suppression, Cushing's syndrome, and
intracranial hypertension have been reported in children
receiving topical corticosteroids. Manifestations of
adrenal suppression in children include linear growth
retardation, delayed weight gain, low plasma cortisol
levels, and subnormal response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging
fontanelles, headaches, and bilateral papilledema.

Because of a higher ratio of skin surface area to body
mass, children are at a greater risk for systemic adverse
reactions than are adults when treated with topical
corticosteroids. [See Warnings and Precautions (5.1)]

8.4.2 Evaluation in Peanut-Sensitive Pediatric Subjects
A clinical study was conducted to assess the safety of
Derma-Smoothe/FS, which contains refined peanut oil, on
subjects with known peanut allergies. The study enrolled
13 subjects with atopic dermatitis, 6 to 17 years of age. Of
the 13 subjects, 9 were Radioallergosorbent Test (RAST)
positive to peanuts and 4 had no peanut sensitivity
(controls). The study evaluated the subjects’ responses to
both prick test and patch test utilizing peanut oil NF,
Derma-Smoothe/FS and histamine/saline controls. Subjects
were also treated with Derma-Smoothe/FS twice daily for 7
days. Prick test and patch test results for all 13 patients
were negative to Derma-Smoothe/FS and the refined
peanut oil. One of the 9 peanut-sensitive patients
experienced an exacerbation of atopic dermatitis after 5
days of Derma-Smoothe/FS. The bulk peanut oil NF, used
in Derma-Smoothe/FS is heated at 475°F for at least 15
minutes, which should provide for adequate decomposition
of allergenic proteins. [See Description (11)]

8.4.3 Evaluation in Pediatric Subjects 2 to 6 years old
An open-label safety studies were conducted on 33 children
(20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12
years) with moderate to severe stable atopic dermatitis.
Subjects were treated with Derma-Smoothe/FS twice daily
for 4 weeks. Baseline body surface area involvement was
50% to 75% in 15 subjects and greater than 75% in 18
subjects. Morning pre-stimulation cortisol and post-ACTH
stimulation cortisol levels were obtained in each subject at
the beginning of the trial and at the end of 4 weeks of
treatment. At the end of treatment, 4 out of 18 subjects
aged 2 to 5 years showed low pre-stimulation cortisol
levels (3.2 to 6.6 μg/dL; normal: cortisol > 7μg/dL) but all
had normal responses to 0.25 mg of ACTH stimulation
(cortisol > 18 μg/dL).

8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years old
An open-label safety study was conducted in 29
children (7 subjects ages 3 to 6 months, 7 subjects ages > 6
to 12 months and 15 subjects ages > 12 months to 2 years
of age) to assess the HPA axis by ACTH stimulation
testing following use of Derma-Smoothe/FS twice daily for
4 weeks. All subjects had moderate to severe atopic
dermatitis with disease involvement on at least 20% body
surface area. Baseline body surface area involvement was
50% to 75% in 11 subjects and greater than 75% in 7
subjects. Morning pre-stimulation and post-ACTH
stimulation cortisol levels were obtained in each subject at
the beginning of the trial and at the end of 4 weeks of
treatment. All subjects had normal responses to 0.125 mg
of ACTH stimulation (cortisol > 18 μg/dL).

10 OVERDOSAGE
Topically applied corticosteroids can be absorbed in
sufficient amounts to produce systemic effects, including
under conditions of normal use. [See Warnings and
Precautions (5.1) and Use in Specific Populations (8.4)].

11 DESCRIPTION
Derma-Smoothe/FS® (fluocinolone acetonide),
Topical Oil, 0.01% (Body Oil) contains fluocinolone
acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-
16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-
3,20-dione, cyclic 16,17 acetal with acetone], a synthetic
corticosteroid for topical dermatologic use. This
formulation is also marketed as Derma-Smoothe/FS®
(fluocinolone acetonide), Topical Oil, 0.01% (Scalp Oil)
0.01% fluocinolone acetonide for use with shower caps for
treatment of scalp psoriasis in adults and as fluocinolone
acetonide oil, 0.01% for treatment of chronic eczematous
external otitis. Chemically, fluocinolone acetonide is C24
H30 F2 O6. It has the following structural formula:

Fluocinolone acetonide in Derma-Smoothe/FS has a
molecular weight of 452.50. It is a white crystalline
powder that is odorless, stable in light, and melts at 270°C
with decomposition; soluble in alcohol, acetone and
methanol; slightly soluble in chloroform; insoluble in
water.

Each gram of Derma-Smoothe/FS contains
approximately 0.11 mg of fluocinolone acetonide in a blend
of oils, which contains isopropyl alcohol, isopropyl
myristate, light mineral oil, oleth-2, refined peanut oil NF
and fragrances.

Derma-Smoothe/FS is formulated with 48% refined
peanut oil NF. The peanut oil used in Derma-Smoothe/FS
is tested for peanut proteins through amino acid analysis
which can detect the quantity of amino acids to below 0.5
parts per million.

12 CINICAL PHARMACOLOGY

12.1 Mechanism of Action
Like other topical corticosteroids, fluocinolone
acetonide has anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the antiinflammatory
activity of the topical steroids, in general, is
unclear. However, corticosteroids are thought to act by the
induction of phospholipase A2 inhibitory proteins,
collectively called lipocortins. It is postulated that these
proteins control the biosynthesis of potent mediators of
inflammation such as prostaglandins and leukotrienes by
inhibiting the release of their common precursor
arachidonic acid. Arachidonic acid is released from
membrane phospholipids by phospholipase A2.

12.3 Pharmacokinetics
Topical corticosteroids can be absorbed from intact
healthy skin. The extent of percutaneous absorption of
topical corticosteroids is determined by many factors,
including the product formulation and the integrity of the
epidermal barrier. Occlusion, inflammation and/or other
disease processes in the skin may increase percutaneous
absorption. The use of pharmacodynamic endpoints for
assessing the systemic exposure of topical corticosteroids
may be necessary due to the fact that circulating levels are
often below the level of detection. Once absorbed through
the skin, topical corticosteroids are metabolized, primarily
in the liver, and are then excreted by the kidneys. Some
corticosteroids and their metabolites are also excreted in the
bile.
Derma-Smoothe/FS is in the low to medium range of
potency as compared with other topical corticosteroids in
vasoconstrictor studies.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, mutagenesis, impairment of fertility:
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility
of Derma-Smoothe/FS. Studies have not been performed
to evaluate the mutagenic potential of fluocinolone
acetonide, the active ingredient in Derma-Smoothe/FS.
Some corticosteroids have been found to be genotoxic in
various genotoxicity tests (i.e. the in vitro human peripheral
blood lymphocyte chromosome aberration assay with
metabolic activation, the in vivo mouse bone marrow
micronucleus assay, the Chinese hamster micronucleus test
and the in vitro mouse lymphoma gene mutation assay).

16 HOW SUPPLIED / STORAGE AND HANDLING
Derma-Smoothe/FS is supplied in bottles containing 4
fluid ounces. It is labeled as Body Oil (NDC # 28105-150-
04).

Storage:
Store at 25°C (68°-77°F); excursions permitted to 15°-
30°C (59°-86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

17.1 Instructions

• Derma-Smoothe/FS should be used as
  directed by the physician. It is for external
  use only. Avoid contact with the eyes. In
  case of contact, wash eyes liberally with
  water.
• Derma-Smoothe/FS should not be used for
  any disorder other than that for which it was
  prescribed.
  
• Patients should report any worsening of their
  skin condition to their physician promptly.
  
• Derma-Smoothe/FS should not be applied
  under occlusion unless directed by the
  physician. Derma-Smoothe/FS should not be
  applied to the diaper area as diapers or
  plastic pants may constitute occlusive use.
  
• Derma-Smoothe/FS should not be used on
  the face, axillae, or groin unless directed by
  the physician.
  
• As with other corticosteroids, therapy should
  be discontinued when control of disease is
  achieved. Contact the physician if no
  improvement is seen within 2 weeks.
  
• Do not use other corticosteroid-containing
  products while using Derma-Smoothe/FS
  without first consulting your physician.
  

MANUFACTURED and DISTRIBUTED BY:
Hill Dermaceuticals, Inc.
Sanford, Florida 32773

Code: 171A189
Date: 12/2007