Label: ZINC OXIDE ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 68786-226-01, 68786-226-02 - Packager: Sion Biotext Medical Ltd
- 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 January 22, 2010
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- ACTIVE INGREDIENT
- Uses:
- Warnings:
- When using this product:
- Stop use and ask a doctor if:
- Keep out of reach of children.
- Directions:
- Other information:
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INGREDIENTS AND APPEARANCE
ZINC OXIDE
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68786-226 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYLUREA (UNII: H5RIZ3MPW4) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM BORATE (UNII: 91MBZ8H3QO) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) CORN OIL (UNII: 8470G57WFM) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68786-226-01 6 in 1 CASE 1 144 in 1 BOX 1 5 g in 1 PACKET 2 NDC:68786-226-02 6 in 1 CASE 2 36 in 1 BOX 2 15 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/01/2010 Labeler - Sion Biotext Medical Ltd (532775194) Registrant - Dynarex Corporation (008124359) Establishment Name Address ID/FEI Business Operations Sion Biotext Medical Ltd 532775194 manufacture