PeriShield

PeriShield

Drug Labeling and Warnings

Drug Details

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AMERIDERM PERISHIELD- zinc oxide ointment 
Shield Line LLC

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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PeriShield

Active Ingredient

Zinc Oxide 3.8%

Purpose

Skin Protectant

Uses

■ Helps treat and prevent diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash an ■ 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 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, Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Lauryl Sulfate, Stearic Acid, Vitamin A Palmitate, Water

Package Label

Principal Display & Drug Fact Panel

AMERIDERM  PERISHIELD
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52410-8020
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
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
CORN OIL (UNII: 8470G57WFM)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52410-8020-4452 g in 1 JAR; Type 0: Not a Combination Product01/01/2015
2NDC: 52410-8020-0100 g in 1 TUBE; Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2015
Labeler - Shield Line LLC (078518916)

Revised: 11/2019
 
Shield Line LLC


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