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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Drug Facts

Active Ingredient

Zinc Oxide (1.8%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

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, aeteth-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

image description

MEDPRIDE  EN SHIELD ALOE SOFT VITAMIN ENRICHED
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52410-3060
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.8 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
CETETH-10 (UNII: LF9X1PN3XJ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ACETATE (UNII: 4Q43814HXS)  
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:52410-3060-2 5 g in 1 PACKET
2 NDC:52410-3060-3 15 g in 1 PACKET
3 NDC:52410-3060-4 113 g in 1 TUBE
4 NDC:52410-3060-5 453 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 05/27/2013
Labeler - Shield Line LLC (078518916)

Revised: 6/2013
Document Id: 0c340877-7f98-4eaa-a78c-3acce9fa95fd
Set id: 2e4f1d9b-35ba-4f7e-8fa0-df1af9f61f95
Version: 2
Effective Time: 20130626
 
Shield Line LLC