Label: DIAPER RASH- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 63941-418-04 - Packager: Valu Merchandisers, Co.
- 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 December 29, 2018
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INGREDIENTS AND APPEARANCE
DIAPER RASH
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-418 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 400 mg in 1 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) TALC (UNII: 7SEV7J4R1U) WATER (UNII: 059QF0KO0R) PARAFFIN (UNII: I9O0E3H2ZE) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) COD LIVER OIL (UNII: BBL281NWFG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63941-418-04 1 in 1 BOX 01/30/2012 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/30/2012 Labeler - Valu Merchandisers, Co. (868703513)