Label: ABC ARBONNE BABY CARE DIAPER RASH- dimethicone and zinc oxide cream

  • NDC Code(s): 42508-331-03
  • Packager: Arbonne International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Dimethicone 1%
    Zinc Oxide 12%

  • 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 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 or soiled diapers promptly, cleanse the diaper area and 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 between 20°C–25°C/68°F–77°F
  • Inactive ingredients

    water, dicaprylyl carbonate, diisopropyl sebacate, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-4 isostearate, dipentaerythrityl tri-polyhydroxystearate, glycerin, glyceryl behenate/eicosadioate, helianthus annuus (sunflower) seed oil unsaponifiables, arnica montana flower extract, calendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf juice, cera carnauba/copernicia cerifera (carnauba) wax, tocopherol, magnesium sulfate, sodium chloride, sodium stearate, chlorphenesin, phenoxyethanol.

  • Questions or comments?

    1.800.272.6663

    Monday–Friday 6 a.m.–6 p.m. Pacific time

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Arbonne International, LLC
    Greenwood, IN 46143 USA

  • PRINCIPAL DISPLAY PANEL - 141 g Tube Carton

    ABC
    ARBONNE BABY CARE®

    DIAPER RASH CREAM

    Net wt. 5 oz./141 g

    PRINCIPAL DISPLAY PANEL - 141 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ABC ARBONNE BABY CARE DIAPER RASH 
    dimethicone and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42508-331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
    SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42508-331-031 in 1 CARTON06/30/2023
    1141 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01606/30/2023
    Labeler - Arbonne International, LLC (961643454)
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