Label: MEMBERS MARK DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 21, 2018

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  • Active ingredient

    Zinc Oxide 13%

    Purpose

    Skin protectant

  • Uses

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

    For external use only.

    When using this product

    Do not get into eyes.

    Stop using this product and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use on

    • deep puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • change wet and soiled diapers promptly
    • clean the diaper area and allow to dry
    • apply ointment liberally as often as required with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other information

    store between 20°C - 25°C (68°F - 77°F)

  • Inactive ingredients

    Water (Aqua), Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Aloe Barbadensis Leaf Juice, Glycerin, Tropolone, Tocopheryl Acetate, Panthenol, 1,2-Hexanediol, Caprylyl Glycol, Magnesium Sulfate, Potassium Hydroxide.

  • Questions or comments?

    1-888-301-0332

  • Label copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    MEMBERS MARK DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-002-07170 g in 1 TUBE; Type 0: Not a Combination Product03/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/20/2018
    Labeler - Sams West Inc (051957769)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(68196-002)
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