Label: ZINC OXIDE cream
- NDC Code(s): 0363-1226-26
- Packager: Walgreen Co
- 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 December 19, 2022
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- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
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INGREDIENTS AND APPEARANCE
ZINC OXIDE
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1226 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 130 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) YELLOW WAX (UNII: 2ZA36H0S2V) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) TROPOLONE (UNII: 7L6DL16P1T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1226-26 1 in 1 CARTON 01/31/1994 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/31/1994 Labeler - Walgreen Co (008965063) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(0363-1226) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(0363-1226)