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

  • 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 July 12, 2016

If you are a consumer or patient please visit this version.

  • 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

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

  • Questions or comments?

    1.800.272.6663
    Monday–Friday 6 a.m.–6 p.m. PST

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Arbonne International, LLC
    9400 Jeronimo Road
    Irvine, CA 92618 U.S.A.

  • 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:42508-529
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42508-529-031 in 1 CARTON09/20/2014
    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 FINALpart34709/20/2014
    Labeler - Arbonne International, LLC (021541164)