Label: BABYGANICS DIAPER RASH- zinc oxide cream

  • NDC Code(s): 59062-1219-1
  • Packager: KAS Direct LLC dba BabyGanics
  • 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 February 4, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc oxide 15%

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash
    • helps seal out wetness
  • 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.

  • Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area
    • 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
  • Other information

    Store at room temperature 59-77°F (15-25°C)

  • Inactive ingredients

    water, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, prunus amygdalus dulcis (sweet almond) oil, glycol stearate, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3 polyricinoleate, glycerin, tocopheryl acetate, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, calendula officinalis flower extract, aloe barbadensis leaf juice, sorbitan sesquioleate, cetyl ricinoleate, glyceryl caprate, beeswax, sodium polyacryloyldimethyl taurate, hydroxyethylcellulose, hydrogenated polydecene, trideceth-10, butylene glycol, magnesium stearate, aluminum tristearate, sodium benzoate, gluconolactone

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    KAS Direct, LLC.
    Hicksville, NY 11801

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    treats &
    protects

    babyganics®

    diaper rash cream

    with zinc oxide, calendula, aloe &
    jojoba ∙ helps prevent diaper rash
    promotes healing ∙ non allergenic
    pediatrician & dermatologist tested

    no: parabens, phthalates, petroleum,
    mineral oil, dyes or fragrances

    + NeoNourish® Natural Seed Oil Blend

    4 OZ (113g)

    Principal Display Panel - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BABYGANICS DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEANUT OIL (UNII: O88E196QRF)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    CETYL RICINOLEATE (UNII: 1P677500YD)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SODIUM TAURATE (UNII: Y7LJA74T0N)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-1219-11 in 1 CARTON06/21/2013
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/21/2013
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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