Label: CMC ZINC OXIDE- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 71168-3040-3, 71168-3040-4, 71168-3040-5 - Packager: SKYLARK CMC PRIVATE LIMITED
- 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 September 11, 2017
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Purpose
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
CMC ZINC OXIDE
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71168-3040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength CETETH-20 (UNII: I835H2IHHX) PETROLATUM (UNII: 4T6H12BN9U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LIGHT MINERAL OIL (UNII: N6K5787QVP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71168-3040-3 28 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2017 2 NDC:71168-3040-4 56 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2017 3 NDC:71168-3040-5 425 g in 1 JAR; Type 0: Not a Combination Product 09/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/01/2017 Labeler - SKYLARK CMC PRIVATE LIMITED (650174824)