Label: MMM DIAPER RASH CREAM- zinc oxide gel 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 January 1, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Zinc Oxide 5% Skin Protectant

  • PURPOSE

    • Helps treat and prevent diaper rash.

    • Protects chafed skin associated with diaper rash and helps protect from wetness.

  • WARNINGS

    For external use only. When using this product avoid contact with 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Change wet and soiled diapers promptly. Cleanse the affected area, and allow to dry. Apply cream liberally as often as necessary, with each change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • STOP USE

    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.

  • DOSAGE & ADMINISTRATION

    Change wet and soiled diapers promptly. Cleanse the affected area, and allow to dry. Apply cream liberally as often as necessary, with each change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • INACTIVE INGREDIENT

    Purified Water, cyclotetrasiloxane , Isopropyl palmitate, Ethylhexyl palmitate, Glycerin, Cyclopentasiloxane, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Dimethicone, Tocopherol (Vitamin E), Zea Mays Oil, Retinyl palmitate(Vitamin A), Cholecalciferol (Vitamin D), Beeswax, Hydrogenated Castor Oil, Sodium Chloride, DMDM Hydantoin.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away

  • MMM Diaper Rash Cream

    MMM Diaper Rash Cream

  • INGREDIENTS AND APPEARANCE
    MMM DIAPER RASH CREAM 
    zinc oxide gel cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    WATER (UNII: 059QF0KO0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MONOPHENYLHEPTAMETHYLCYCLOTETRASILOXANE (UNII: 50Q464790P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-007-60170 g in 1 TUBE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2021
    Labeler - Southern Sales & Services, Inc. (013114906)
    Registrant - Southern Sales & Services, Inc. (013114906)
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