DERMA-SMOOTHE/FS .11 mg/mL
fluocinolone acetonide · OIL · Royal Pharmaceuticals
DERMA-SMOOTHE/FS is a oil containing fluocinolone acetonide at .11 mg/mL, taken topical. Manufactured by Royal Pharmaceuticals.
Key Facts
- Brand Name
- DERMA-SMOOTHE/FS
- Generic Name
- fluocinolone acetonide
- NDC Code (Product)
68791-102- Manufacturer
- Royal Pharmaceuticals
- Strength
- .11 mg/mL
- Dosage Form
- OIL
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA019452
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 02/16/1995
Recall History
Hill Dermaceuticals, Inc.
Subpotent; fluocinolone acetonide
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent; 22 month stability timepoint
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent; fluocinolone acetonide
Hill Dermaceuticals, Inc.
Subpotent; 12 month stability timepoint
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Full Prescribing Information
Indications & Usage
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.
Dosage & Administration
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…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
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 t…
Frequently Asked Questions
What is DERMA-SMOOTHE/FS used for?
DERMA-SMOOTHE/FS contains fluocinolone acetonide. It is a oil taken topical. Consult your doctor for specific uses.
Is DERMA-SMOOTHE/FS a controlled substance?
DERMA-SMOOTHE/FS is not classified as a controlled substance by the DEA.
What is the generic name for DERMA-SMOOTHE/FS?
The generic name for DERMA-SMOOTHE/FS is fluocinolone acetonide. There are 12 other brand versions of fluocinolone acetonide.
What is the NDC code for DERMA-SMOOTHE/FS .11 mg/mL?
The NDC (National Drug Code) for DERMA-SMOOTHE/FS .11 mg/mL is 68791-102, listed by Royal Pharmaceuticals.
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- Synalar.25 mg/g43538-900
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- DERMOTIC.11 mg/mL68791-103
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- FLUOCINOLONE ACETONIDE Oil.11 mg/mL64980-330
- Fluocinolone Acetonide.1 mg/mL43386-069
- fluocinolone acetonide.1 mg/g62559-288
- Fluocinolone Acetonide Oil.11 mg/mL64980-331
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)