MedPride Enshield

MedPride Enshield

Drug Labeling and Warnings

Drug Details

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MEDPRIDE  EN SHIELD ALOE SOFT VITAMIN ENRICHED- zinc oxide cream 
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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MedPride Enshield

Active Ingredient

Zinc Oxide (3.8%w/w)

Purpose

Skin Protectant

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Warnings

For external use only

When using this product

■ do not get into eyes

Stop Use and ask a doctor if

conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

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 ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive ingredients

aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender
methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium
steareth-20, trolamine, vitamin A, water, FDC Yellow No.5, DC Red No.21

Package Label

Package Label

MEDPRIDE   EN SHIELD ALOE SOFT VITAMIN ENRICHED
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52410-3066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
CETETH-10 (UNII: LF9X1PN3XJ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TROLAMINE (UNII: 9O3K93S3TK)  
VITAMIN A (UNII: 81G40H8B0T)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52410-3066-499.2 g in 1 TUBE; Type 0: Not a Combination Product05/27/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/27/2013
Labeler - Shield Line LLC (078518916)

Revised: 1/2019
 
Shield Line LLC


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