Label: ASTONEA PERISHIELD- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 77338-802-00, 77338-802-04 - 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 August 9, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
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Directions
■ Change wet and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged
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Inactive ingredients
Aloe Barbadensis Gel, Alpha Tocopherol (Vitamin E), Cholecalciferol (Vitamin D), Chloroxylenol, Cetostearyl Alcohol, Corn Oil, Ethylhexylglycerin, FD&C Yellow No. 5, FD&C Yellow No. 6, Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Laureth-3 Sulfate, Stearic Acid, Vitamin A Palmitate, Water
- Package Label
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INGREDIENTS AND APPEARANCE
ASTONEA PERISHIELD
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-802 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.8 g in 100 g Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 5 (UNII: I753WB2F1M) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHLOROXYLENOL (UNII: 0F32U78V2Q) CHOLECALCIFEROL (UNII: 1C6V77QF41) CORN OIL (UNII: 8470G57WFM) LANOLIN (UNII: 7EV65EAW6H) PHENOXYETHANOL (UNII: HIE492ZZ3T) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM BORATE (UNII: 91MBZ8H3QO) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77338-802-04 452 g in 1 JAR; Type 0: Not a Combination Product 08/09/2022 2 NDC:77338-802-00 100 g in 1 TUBE; Type 0: Not a Combination Product 08/09/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/09/2022 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)