Label: ZINC OXIDE- zinc oxide ointment
- NDC Code(s): 67777-222-01, 67777-222-02, 67777-222-03
- Packager: Dynarex Corporation
- 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.
Updated May 16, 2016
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- ACTIVE INGREDIENT
Active Ingredient Purpose
Zinc Oxide (200mg in each gram) Skin ProtectantClose
- Helps treat and prevent diaper rash.
- Dries the oozing and weeping of;
- poison ivy
- poison oak
- poison sumac
For External Use OnlyClose
- When using this product:
- Do not get in eyes.
- Do not get in eyes.
- Stop use and ask a doctor if:
- conditions worsens
- symptoms last more than 7 days or clear up and occur again in a few days, consult a physician.
- over large areas of the body
- if you are allergic to any of these ingredients
- Do not use on:
- deep or puncture wounds
- animal bites
- serious burns
- Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Close
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
Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft ParaffinClose
- Principal Display
- INGREDIENTS AND APPEARANCE
zinc oxide ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-222 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 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:67777-222-03 28.34 g in 1 TUBE; Type 0: Not a Combination Product 03/17/2010 2 NDC:67777-222-01 56.68 g in 1 TUBE; Type 0: Not a Combination Product 03/17/2010 3 NDC:67777-222-02 425.1 g in 1 JAR; Type 0: Not a Combination Product 03/17/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/16/2010 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Pvt. Ltd. 864201135 manufacture(67777-222) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Pvt. Ltd. 650970176 manufacture(67777-222) Establishment Name Address ID/FEI Business Operations Blossom Pharmaceuticals 677381470 manufacture(67777-222)