QUALITY CHOICE MAXIMUM STRENGTH DIAPER RASH- zinc oxide cream 
Chain Drug Marketing Association

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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Maximum Strength Diaper Rash Paste

Active ingredient

Zinc Oxide, 40.0%

Purpose

Skin protectant

Uses

•
helps treat and prevent diaper rash
•
protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only.

When using this product

•
do not get into eyes

Stop use and ask a doctor if

•
condition worsens
•
symptoms last more than 7 days or clear up and occur again within a few 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
•
cleanse the diaper area
•
allow to dry
•
apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other Information

•
store at 20° to 25°C (68° to 77°F)

Inactive ingredients

cod liver oil, talc, petrolatum, lanolin, water, methylparaben, fragrance, BHA

Package/Label Principal Display Panel

Maximum Strength Diaper Rash Paste
With 40% Zinc Oxide

Helps To Heal, Soothe & Prevent Diaper Rash

NET WT 4 OZ. (113 g)

*Compare to DESITIN® MAXIMUM STRENGTH

Maximum Strength Original Diaper Rash Paste provides overnight relief for your baby's delicate skin. This rich, dermatologist-tested and hypoallergenic formula contains the maximum level of zinc oxide to instantly form a protective barrier to help heal and soothe discomfort caused by diaper rash.

*This product is not manufactured or distributed by Johnson & Johnson®
Consumer Products Company, owner of the registered trademark Desitin®

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Manufactured in Israel
0D927 CD C1

SATISFACTION GUARANTEED

Carton Label

Carton Label

QUALITY CHOICE MAXIMUM STRENGTH DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-165
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COD LIVER OIL (UNII: BBL281NWFG)  
TALC (UNII: 7SEV7J4R1U)  
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-165-051 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2014
Labeler - Chain Drug Marketing Association (011920774)

Revised: 4/2014
Document Id: 5bec85c7-d69c-4ca7-a345-950cc030f41e
Set id: 5bec85c7-d69c-4ca7-a345-950cc030f41e
Version: 1
Effective Time: 20140408
 
Chain Drug Marketing Association