Derma-Smoothe/FS
- Product NDC
- 68791-101
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluocinolone acetonide
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Royal Pharmaceuticals
- Application
- NDA019452
- Marketing category
- NDA
- Substance
- FLUOCINOLONE ACETONIDE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 68791-101-01 | 1 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE | 20240506 | | Yes | Historical |
| 68791-101-04 | 1 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLE | 19950216 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| bc61c619-a71c-46f5-80f1-9e9ee71134aa | 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 Not for Oral, Ophthalmic, or Intravaginal Use NDC 68791-101-04 Initial U.S. Approval: 1988 | Royal Pharmaceuticals | 2025-06-30 | HUMAN PRESCRIPTION DRUG LABEL | 13 |