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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52410-3060
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALPHA-TOCOPHEROL 
CETETH-10 
CETOSTEARYL ALCOHOL 
CETYL ACETATE 
CHOLECALCIFEROL 
GLYCERIN 
LANOLIN 
LAVENDER OIL 
METHYLPARABEN 
MINERAL OIL 
PARAFFIN 
PETROLATUM 
PHENOXYETHANOL 
POLYETHYLENE GLYCOL 6000 
POLYSORBATE 60 
PROPYLPARABEN SODIUM 
STEARETH-20 
TROLAMINE 
VITAMIN A 
WATER 
FD&C YELLOW NO. 5 
D&C RED NO. 21 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52410-3060-25 g in 1 PACKET
2NDC:52410-3060-315 g in 1 PACKET
3NDC:52410-3060-4113 g in 1 TUBE
4NDC:52410-3060-5453 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/27/2013
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