Label: QUALITY CHOICE MAXIMUM STRENGTH DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 8, 2014

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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