ASTONEA PERISHIELD- zinc oxide ointment 
ASTONEA LABS PRIVATE LIMITED

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.

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astonea PeriShield

Active Ingredient

Zinc Oxide 3.8%

Purpose

Skin Protectant

Uses

■ Helps treat and prevent rash associated with diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash and ■ Helps protect skin from exposure to wetness

Warnings

For external use only

When using this product

■ Avoid contact with eyes ■ If eye contact, occurs, flush with water

Stop Use and ask a doctor if

■ condition worsens or doesn't improve within seven days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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

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

Principal Display and Drug Fact Panel

ASTONEA  PERISHIELD
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-802
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-802-04452 g in 1 JAR; Type 0: Not a Combination Product08/09/2022
2NDC:77338-802-00100 g in 1 TUBE; Type 0: Not a Combination Product08/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/09/2022
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 8/2022
Document Id: e5d284fc-a71a-a598-e053-2a95a90a539a
Set id: e5d284f3-839e-cd25-e053-2995a90ad479
Version: 1
Effective Time: 20220809
 
ASTONEA LABS PRIVATE LIMITED