Label: ZINC OXIDE ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 50382-051-01, 50382-051-02, 50382-051-03 - Packager: Galentic Pharma (India) Priva Te Limited
- Category: HUMAN OTC DRUG LABEL
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 July 26, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses:
- Warnings:
- When using this product:
- Stop use and ask a doctor if:
- Do not use on:
- 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 with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
For poison ivy, poison oak, poison sumac:
- apply liberally as often as needed
- Inactive Ingredients
- Principal Display
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INGREDIENTS AND APPEARANCE
ZINC OXIDE
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-051 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) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-051-03 72 in 1 CASE 1 28.34 g in 1 TUBE 2 NDC:50382-051-01 72 in 1 CASE 2 56.68 g in 1 TUBE 3 NDC:50382-051-02 12 in 1 CASE 3 425.1 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/19/2013 Labeler - Galentic Pharma (India) Priva Te Limited (918531450) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Priva Te Limited 918531450 manufacture(50382-051)