Label: ASTONEA SKIN PROTECTANT- zinc oxide ointment
- NDC Code(s): 77338-050-04
- Packager: ASTONEA LABS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 25, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses:
- Warnings:
-
Directions:
- Change wet or solied diapers promptly
- Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs
- Allow to dry
- Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time when exposure to soiled diapers may be prolonged
- Other information:
-
Inactive ingredients:
Aloe Barbadensis Gel, Alpha-Tocopherol(Vitamin E), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), Ethylhexylglycerine, FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, Sodium Laureth-3 Sulfate, stearic acid, Vitamin A Palmitate, Water.
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ASTONEA SKIN PROTECTANT
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 18 mg in 1 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAVENDER OIL (UNII: ZBP1YXW0H8) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) STEARIC ACID (UNII: 4ELV7Z65AP) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHOLECALCIFEROL (UNII: 1C6V77QF41) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77338-050-04 113 g in 1 TUBE; Type 0: Not a Combination Product 08/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/21/2019 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295) Establishment Name Address ID/FEI Business Operations ASTONEA LABS PRIVATE LIMITED 878533295 manufacture(77338-050)