Label: ZINC OXIDE ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 63777-222-01, 63777-222-02, 63777-222-03 - Packager: Kinray 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 April 25, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Warnings:
- When using this product:
- Stop use and ask a doctor if:
- Do not use on:
- Keep out of reach of children
- Inactive Ingredient
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Dosage and Administration
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
- Indications and Usage
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ZINC OXIDE
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63777-222 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 LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63777-222-03 72 in 1 CASE 1 28.34 g in 1 TUBE 2 NDC:63777-222-01 72 in 1 CASE 2 56.68 g in 1 TUBE 3 NDC:63777-222-02 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 04/19/2010 Labeler - Kinray Inc. (012574513) Registrant - Dynarex Corporation (008124539) Establishment Name Address ID/FEI Business Operations Galentic Pharma India Private Limited 918531450 manufacture(63777-222) Establishment Name Address ID/FEI Business Operations Blossom Pharmaceuticals 677381470 manufacture(63777-222)