DERMA-SMOOTHE/FS

DERMA-SMOOTHE/FS is an FDA-registered drug product whose active ingredient is FLUOCINOLONE ACETONIDE. It is labelled by Royal Pharmaceuticals taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 68791-102, application NDA019452, label effective 20260609. It is one of 14 FDA drug label records sharing the active ingredient FLUOCINOLONE ACETONIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FLUOCINOLONE ACETONIDE are most often described in connection with: derma-smoothe scalp, treatment psoriasis, oil corticosteroid. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Derma-Smoothe/FS ® Scalp Oil is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults. ( 1 ) DERMA-SMOOTHE/FS ® Scalp Oil is indicated for the treatment of psoriasis of the scalp in adults.

2 DOSAGE AND ADMINISTRATION DERMA-SMOOTHE/FS Scalp Oil is for topical use only. Not for oral, ophthalmic, or intravaginal use. Wet or dampen hair and scalp thoroughly. Apply a thin film of DERMA-SMOOTHE/FS Scalp Oil on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours then wash hair with regular shampoo and rinse thoroughly. Use daily as needed. Discontinue DERMA-SMOOTHE/FS Scalp Oil when control of disease is achieved within 2 weeks, or contact the healthcare provider if no improvement is seen within 2 weeks. Do not use DERMA-SMOOTHE/FS Scalp Oil on the face unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions [see Adverse Reactions (6) ] . Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use. [see Warnings and Precautions (5.1) ] DERMA-SMOOTHE/FS Scalp Oil is not for oral, ophthalmic, or intravaginal use. ( 2 ) Do not use on face or intertriginous areas. ( 2 ) Apply a thin film of DERMA-SMOOTHE/FS Scalp Oil on the wet scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. ( 2 )

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: • Endocrine System Adverse Reactions [see Warnings and Precautions (5.1) ] • Local Adverse Reactions [see Warnings and Precautions (5.2) ] • Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions in pediatric subjects treated for atopic dermatitis (≥5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%). ( 6.1 , 6.2 ) 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. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying condition, 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. An open-label safety study was conducted in 29 pediatric subjects 3 months to 2 years old to assess the HPA axis by ACTH stimulation testing following use of the formulation of DERMA-SMOOTHE/FS Scalp Oil twice daily for 4 weeks. DERMA-SMOOTHE/FS Scalp Oil is not approved for use in pediatric patients for the treatment of psoriasis of the scalp. The most common adverse reactions were reported in the study: Table 1: Adverse Reactions in ≥2% Pediatric Subjects 3 Months to 2 Years of Age Treated with the Formulation of DERMA-SMOOTHE/FS Scalp Oil, N=30 Includes one subject who withdrew at Week 2 Adverse Reaction n (%) Cough 6 (20) Rhinorrhea 4 (13) Pyrexia 3 (10) Nasopharyngitis 2 (7) Hypopigmentation 2 (7) Abscess 1 (3) Atopic Dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Molluscum 1 (3) Rash 1 (3) Diarrhea 1 (3) Otitis Media 1 (3) URI 1 (3) Vomiting 1 (3) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Endocrine Disorders: HPA axis suppression and Cushing’s syndrome Eye Disorders: glaucoma and cataracts Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema

FDA lists 14 drug label records with FLUOCINOLONE ACETONIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is DERMA-SMOOTHE/FS used for?
1 INDICATIONS AND USAGE Derma-Smoothe/FS ® Scalp Oil is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults. ( 1 ) DERMA-SMOOTHE/FS ® Scalp Oil is indicated for the treatment of psoriasis of the scalp in adults.

Who makes DERMA-SMOOTHE/FS?
Royal Pharmaceuticals is the labeler of record for DERMA-SMOOTHE/FS. 14 FDA label records share the active ingredient FLUOCINOLONE ACETONIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does DERMA-SMOOTHE/FS come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is DERMA-SMOOTHE/FS prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FLUOCINOLONE ACETONIDE?
Yes. 14 FDA drug label records list FLUOCINOLONE ACETONIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has DERMA-SMOOTHE/FS been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.