Your browser does not support JavaScript! MAXIMUM STRENGTH ORIGINAL DIAPER RASH (ZINC OXIDE) CREAM [AMERICAN SALES COMPANY]
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MAXIMUM STRENGTH ORIGINAL DIAPER RASH (zinc oxide) cream
[American Sales Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 20º to 25ºC (68º to 77ºF)

Inactive ingredients

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

Package/Label Principal Display Panel

Cottontails baby care

maximum strength original diaper rash paste

Take care of your little one, from the top of their head to their tiny little toes, with Cottontails®.

40% zinc oxide

Helps to heal, soothe & prevent diaper rash

Compare to Desitin® Maximum Strength Original Paste ingredients

NET WT. 4 OZ. (113 g)

Designed to be gentle on your little one, our skin care products will keep their skin smooth, soft and ready for the next exciting day.

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 irritation 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 FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949
© 2013 Ahold Licensing, Sarl
MADE IN ISRAEL
Quality guaranteed or your money back.
0D927 D4 C1

Carton Label

Carton Label

MAXIMUM STRENGTH ORIGINAL DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-927
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE400 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
COD LIVER OIL 
TALC 
PETROLATUM 
LANOLIN 
WATER 
METHYLPARABEN 
BUTYLATED HYDROXYANISOLE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-927-111 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/15/2013
Labeler - American Sales Company (809183973)

Revised: 9/2013
 
American Sales Company

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