Label: ZINC OXIDE ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 50382-011-01, 50382-011-02 - Packager: Galentic Pharma (India) 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 August 9, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses:
- Warnings:
- When using this product:
- Stop use and ask a doctor if:
- Keep out of reach of children.
- Dosage and Administration:
- Other information:
- INDICATIONS & USAGE
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Inactive Ingredients
Inactive ingredients:
Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water
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INGREDIENTS AND APPEARANCE
ZINC OXIDE
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.8 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) CETETH-10 (UNII: LF9X1PN3XJ) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL ALCOHOL (UNII: 936JST6JCN) STEARETH-20 (UNII: L0Q8IK9E08) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 60 (UNII: CAL22UVI4M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHOLECALCIFEROL (UNII: 1C6V77QF41) VITAMIN A (UNII: 81G40H8B0T) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) ALOE VERA LEAF (UNII: ZY81Z83H0X) PETROLATUM (UNII: 4T6H12BN9U) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-011-01 114 g in 1 TUBE 2 NDC:50382-011-02 427.5 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/08/2013 Labeler - Galentic Pharma (India) Private Limited (918531450) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Private Limited 918531450 manufacture(50382-011)