Label: TRIPLE 3X MAX DIAPER RASH- zinc oxide ointment

  • NDC Code(s): 16864-061-01, 16864-061-02
  • Packager: Advantice Health, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc oxide 40%

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps protect from wetness
  • Warnings

    For external use only

    When using this productdo 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 and allow skin to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged
  • Other information

    Store at room temperature 15°-30°C (59°-86°F)

  • Inactive ingredients

    avena sativa (oat) kernel extract, beeswax, bisabolol, cholesterol, glycerin, lanolin, mineral oil, water, white petrolatum, zea mays (corn) starch

  • Questions?

    1-800-345-0032

  • SPL UNCLASSIFIED SECTION

    Distributed by Advantice Health, LLC
    Bridgewater, NJ 08807

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

    PEDIATRICIAN RECOMMENDED

    TRIPLE PASTE ®

    40% Zinc Oxide / Skin Protectant

    ACCEPTED
    e
    National
    Eczema
    Association

    Diaper Rash Relief
    3X* MAX
    3X ZINC OXIDE

    PLUS SKIN NOURISHING
    INGREDIENTS

    • Oat Extract
    • Beeswax
    • Glycerin

    Fragrance Free • Hypoallergenic • Talc Free

    Prevents • Treats • Soothes

    Net Wt. 2oz. (57g)

    Principal Display Panel - 57 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TRIPLE 3X MAX DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-061
    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
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OAT (UNII: Z6J799EAJK)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-061-011 in 1 CARTON05/15/2024
    157 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:16864-061-02170 g in 1 TUBE; Type 0: Not a Combination Product10/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/15/2024
    Labeler - Advantice Health, LLC (192527062)
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