Label: QUALITY CHOICE QUICK RELIEF 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, 13.0%

  • 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

    water, petrolatum, mineral oil, beeswax, PEG-30 dipolyhydroxystearate, microcrystalline wax, polyglyceryl-3 diisostearate, dimethicone, sorbitan sesquioleate, magnesium sulfate, phenoxyethanol, tocopheryl acetate (vitamin E), methylparaben, propylparaben, aloe barbadensis leaf juice, fragrance, potassium hydroxide.

  • Package/Label Principal Display Panel

    Quick Relief Diaper Rash Cream
    with Zinc Oxide

    Helps To Heal, Soothe & Prevent Diaper Rash

    NET WT 4 OZ. (113 g)

    *Compare to DESITIN® RAPID RELIEF

    Quick Relief Creamy Diaper Rash Cream provides relief from the very first use by immediately forming a protective layer on your baby’s delicate skin to soothe and relieve discomfort caused by diaper rash. This creamy, dermatologist-tested and hypoallergenic formula goes on smoothly and wipes off easily, to protect and treat diaper rash providing relief your baby can feel.

    *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
    0D827 CD C1

    SATISFACTION GUARANTEED

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE QUICK RELIEF DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ROYAL JELLY (UNII: L497I37F0C)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-164-041 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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