Label: DESITIN DAILY DEFENSE ZINC OXIDE DIAPER RASH- zinc oxide cream
- NDC Code(s): 69968-0603-1, 69968-0603-2, 69968-0603-4, 69968-0603-5
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 7, 2021
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PRINCIPAL DISPLAY PANEL - 454 g Jar Label
#1
CHOICE OF
PEDIATRICIANS & PARENTSDesitin ®
Daily Defense
13% Zinc Oxide Diaper Rash Cream
relieves discomfort
in one applicationprotects against diaper
rash from the first usefree from parabens, phthalates, dyes and fragrance,
Hypoallergic • Pediatrician & Dermatologist testedNET WT 1 lb
16 Oz (454 g) -
INGREDIENTS AND APPEARANCE
DESITIN DAILY DEFENSE ZINC OXIDE DIAPER RASH
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 130 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) YELLOW WAX (UNII: 2ZA36H0S2V) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) TROPOLONE (UNII: 7L6DL16P1T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0603-2 1 in 1 CARTON 12/01/2018 1 57 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69968-0603-4 1 in 1 CARTON 12/01/2018 2 113 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69968-0603-5 1 in 1 CARTON 12/01/2018 3 136 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:69968-0603-1 454 g in 1 JAR; Type 0: Not a Combination Product 12/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/01/2018 Labeler - Johnson & Johnson Consumer Inc. (002347102)