TRIPLE MEDICATED FOR DIAPER RASH (ZINC OXIDE) PASTE [SUMMERS LABORATORIES INC]

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TRIPLE MEDICATED FOR DIAPER RASH (ZINC OXIDE) PASTE [SUMMERS LABORATORIES INC]
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NDC 11086-021-01, 11086-021-02, 11086-021-03, 11086-021-05, 11086-021-06
Set ID f9fd9395-48bc-43be-a3d9-ec7fcad339a9
Category HUMAN OTC DRUG LABEL
Packager Summers Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    ZINC OXIDE 12.8%

  • 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

    When using this product

    • DO NOT GET INTO EYES
  • STOP USE

    Stop and ask a doctor if

    • condition worsens or does not improve within 7 days
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTCT 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
  • INACTIVE INGREDIENTS

    white petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerine, oat (avena sativa) kernel extract, polysorbate 80.

  • PRINCIPAL DISPLAY PANEL

    Triple Paste 2 oz_Unit Carton

    Triple Paste 8oz label

    Triple Paste 16 oz label

  • INGREDIENTS AND APPEARANCE
    TRIPLE   MEDICATED FOR DIAPER RASH
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V) 8 g  in 100 g
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OAT (UNII: Z6J799EAJK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11086-021-0156.7 g in 1 TUBE; Type 0: Not a Combination Product10/30/2013
    2NDC:11086-021-02454 g in 1 JAR; Type 0: Not a Combination Product10/30/2013
    3NDC:11086-021-03240 g in 1 PACKAGE; Type 0: Not a Combination Product10/30/2013
    4NDC:11086-021-05284 g in 1 PACKAGE; Type 0: Not a Combination Product10/30/2013
    5NDC:11086-021-06100 g in 1 PACKAGE; Type 0: Not a Combination Product10/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/30/2013
    Labeler - Summers Laboratories Inc (002382612)
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