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NDC 68791-0102-01 Derma-Smoothe/FS 0.11 mg/mL Details
Derma-Smoothe/FS 0.11 mg/mL
Derma-Smoothe/FS is a TOPICAL OIL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Royal Pharmaceuticals. The primary component is FLUOCINOLONE ACETONIDE.
MedlinePlus Drug Summary
Fluocinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 68791-0102-01Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Fluocinolone Topical
Product Information
| NDC | 68791-0102 |
|---|---|
| Product ID | 68791-102_063282d0-339f-495a-8e2a-ebf51a78970e |
| Associated GPIs | 90550055101714 |
| GCN Sequence Number | 058950 |
| GCN Sequence Number Description | fluocinolone/shower cap OIL 0.01 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 24484 |
| HICL Sequence Number | 032834 |
| HICL Sequence Number Description | FLUOCINOLONE ACETONIDE/SHOWER CAP |
| Brand/Generic | Brand |
| Proprietary Name | Derma-Smoothe/FS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fluocinolone acetonide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | OIL |
| Route | TOPICAL |
| Active Ingredient Strength | 0.11 |
| Active Ingredient Units | mg/mL |
| Substance Name | FLUOCINOLONE ACETONIDE |
| Labeler Name | Royal Pharmaceuticals |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA019452 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68791-0102-01 (68791010201)
| NDC Package Code | 68791-102-01 |
|---|---|
| Billing NDC | 68791010201 |
| Package | 1 BOTTLE in 1 CARTON (68791-102-01) / 20 mL in 1 BOTTLE |
| Marketing Start Date | 2023-10-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |