Z-BUM (DIAPER RASH CREAM) CREAM [GM PHARMACEUTICALS, INC]

Z-BUM (DIAPER RASH CREAM) CREAM [GM PHARMACEUTICALS, INC]
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NDC 58809-375-04
Set ID 2a36f396-3a30-3f3f-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager GM Pharmaceuticals, INC
Generic Name
Product Class
Product Number
Application Number PART347
  • SPL UNCLASSIFIED SECTION

    Z-Bum

    NDC 58809-375-04

    4 oz. (113 grams)

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  • Active ingredient

    Zinc Oxide 22%

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  • Purpose

    Skin Protectant

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  • Uses

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

    Keep out of reach of children.

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

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  • Directions

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

    • Store at 68-77° F (20-25° C) [see USP Controlled Room Temperature]
    • Lot No and Exp Date: see box or see crimp of tube.
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  • Inactive ingredients

    Purified Water, White Petrolatum, Glycerine, Light Mineral Oil, Cetyl Alcohol, Stearyl Alcohol, Ceteareth- 20, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Chlorphenesin, Phenoxyethanol, and Tocopheryl Acetate (Vitamin E).\

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  • Questions or comments?

    1-888-535-0305

    Manufactured for:
    GM Pharmaceuticals, Inc.

    Arlington, TX 76015

    P1117.00

    R071216

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  • PRINCIPAL DISPLAY PANEL

    NDC58809-375-04
    Z-BUM
    Daily Moisturizing Diaper Rash Cream
    NET WT 4 oz (113 grams)

    PRINCIPAL DISPLAY PANEL
NDC58809-375-04
Z-BUM
Daily Moisturizing Diaper Rash Cream
NET WT 4 oz (113 grams)

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  • INGREDIENTS AND APPEARANCE
    Z-BUM 
    diaper rash cream cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-375
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM P-CHLORO-M-CRESOL (UNII: 343KVA8Y38)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58809-375-04 113 g in 1 CARTON; Type 0: Not a Combination Product 12/01/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 12/01/2015
    Labeler - GM Pharmaceuticals, INC (793000860)
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