Label: ASTONEA EN SHIELD ALOE SOFT VITAMIN ENRICHED- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 77338-306-64 - Packager: ASTONEA LABS PRIVATE LIMITED
- 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 10, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- 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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Inactive ingredients
Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Ethylhexylglycerin,FD&C Yellow No. 5, Fragrance, Glycerin, Lanolin, Microcrystalline Wax, Mineral Oil, Paraffin, Phenoxyethanol, Ponceau 4R, Propylene Glycol, Sodium Benzoate, Vitamin A Palmitate, Water
- Package Label
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INGREDIENTS AND APPEARANCE
ASTONEA EN SHIELD ALOE SOFT VITAMIN ENRICHED
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-306 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 3.8 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) CETETH-20 (UNII: I835H2IHHX) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CHOLECALCIFEROL (UNII: 1C6V77QF41) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) PONCEAU 4R (UNII: Z525CBK9PG) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77338-306-64 99.2 g in 1 TUBE; Type 0: Not a Combination Product 02/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/07/2019 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)