Label: BABY MANTRA DIAPER CREAM- zinc oxide 10% ointment

  • NDC Code(s): 76348-825-34
  • Packager: Renu Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 3, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient

    Zinc Oxide 10%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses:

    • Helps treat and prevent diaper rash.
    • Protects chafed skin due to diaper rash and helps protect skin from wetness.
    • Helps prevent and temporarily protects chafed, chapped, cracked or wind-burned skin and lips.
  • WARNINGS

    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

    Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    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

    Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
    • Apply ointment liberally, as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diaper
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax (White), Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (D-alpha), Aqua (Water), Glycerin

  • OTHER SAFETY INFORMATION

    Store at room temperature

  • PRINCIPAL DISPLAY PANEL

    TUBE ARTWORK

    TUBE ARTWORK

  • INGREDIENTS AND APPEARANCE
    BABY MANTRA DIAPER CREAM 
    zinc oxide 10% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-825
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY (UNII: IJ67X351P9)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-825-34100 mL in 1 TUBE; Type 0: Not a Combination Product01/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/03/2024
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-825)
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