Label: NIVAGEN ZINC OXIDE- zinc oxide ointment
- NDC Code(s): 75834-170-01, 75834-170-02, 75834-170-15
- Packager: Nivagen Pharmaceuticals, 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 February 14, 2022
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- ACTIVE INGREDIENT(S)
- USE(S)
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
■ For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
■ For poison ivy, oak, and sumac: Apply as needed.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NIVAGEN ZINC OXIDE
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75834-170 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) PETROLATUM (UNII: 4T6H12BN9U) LIGHT MINERAL OIL (UNII: N6K5787QVP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75834-170-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 05/10/2018 2 NDC:75834-170-02 56.7 g in 1 TUBE; Type 0: Not a Combination Product 05/10/2018 3 NDC:75834-170-15 425 g in 1 JAR; Type 0: Not a Combination Product 05/10/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 05/10/2018 Labeler - Nivagen Pharmaceuticals, Inc. (052032418)
