NDC Code(s) : 70233-001-01
Packager : Fleet Laboratories LTD

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Infant Diaper Cream Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70233-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
GLYCERIN(UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
YELLOW WAX(UNII: 2ZA36H0S2V)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
DIMETHICONE(UNII: 92RU3N3Y1O)
ISOSTEARYL LACTATE(UNII: 8OM3O3YPML)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
MAGNESIUM SULFATE(UNII: DE08037SAB)
PANTHENOL(UNII: WV9CM0O67Z)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALLANTOIN(UNII: 344S277G0Z)
SUNFLOWER OIL(UNII: 3W1JG795YI)
PANTOLACTONE, (+/-)-(UNII: IID733HD2M)
CHAMOMILE FLOWER OIL(UNII: 60F80Z61A9)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70233-001-01100 g in 1 TUBE Type 0: Not a Combination Product10/07/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 07/10/2015

PRINCIPAL DISPLAY PANEL

Infant Diaper Cream

3.4 fl oz (100 g)


 

Drug Facts

 

Drug Facts