DIAPER RASH- zinc oxide cream 
Kareway Product, Inc.

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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Pure-Aid Diaper Rash Cream

Active ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

Warnings

For external use only

Do not use

over deep or puncture wounds, infections or lacerations

When using this product

avoid contact with the eyes

Stop use and ask a doctor

if condition worsens or does not improve within 7 days.

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

aloe barbadensis leaf juice, mineral oil, petrolatum

Package label

Diaper Rash Cream

carton

DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-1502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.13 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-1502-21 in 1 BOX08/25/2011
157 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:67510-1502-41 in 1 BOX08/25/2011
2114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/25/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2023
Document Id: f4ee6f6e-ffc6-4583-e053-2a95a90aa960
Set id: 9885be37-8fbe-64b3-e053-2a95a90ac633
Version: 2
Effective Time: 20230217
 
Kareway Product, Inc.