NDC Code(s) : 68791-101-04
Packager : Royal Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Derma-Smoothe/FSfluocinolone acetonide OIL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68791-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fluocinolone acetonide(UNII: 0CD5FD6S2M)
(fluocinolone acetonide - UNII:0CD5FD6S2M) 		fluocinolone acetonide0.11 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL(UNII: ND2M416302)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
OLETH-2(UNII: 7L6R1SQ6M0)
PEANUT OIL(UNII: 5TL50QU0W4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68791-101-041 in 1 CARTON 16/02/1995
1118.28 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019452 02/16/1995

LABELER - Royal Pharmaceuticals(078374385)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 118.28 mL Bottle Label

NDC 68791-101-04

Rx only

Derma-Smoothe/FS®

Fluocinolone Acetonide
0.01% Topical Oil

(BODY OIL)

FOR TOPICAL USE ONLY
NOT FOR ORAL, OPHTHALMIC,
or INTRAVAGINAL USE

SHAKE WELL BEFORE USE

Net Contents 118.28 mL
(4 fL. oz.)

ROYAL
PHARMACEUTICALS®

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