ABC ARBONNE BABY CARE  DIAPER RASH- dimethicone and zinc oxide cream 
Arbonne International, LLC

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.

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ABC Arbonne Baby Care®
Diaper Rash Cream

Drug Facts

Active ingredients

Dimethicone 1%
Zinc Oxide 12%

Purpose

Skin Protectant

Uses

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

Other information

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

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
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)

Revised: 7/2016
Document Id: d0bbc36d-1442-4a2e-b251-54943388f3d2
Set id: 2666daf3-ba1b-4d39-94a4-391c12ee87bc
Version: 2
Effective Time: 20160712
 
Arbonne International, LLC