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

ABC Arbonne Baby Care by

Drug Labeling and Warnings

ABC Arbonne Baby Care by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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

INGREDIENTS AND APPEARANCE

ABC ARBONNE BABY CARE   DIAPER RASH
dimethicone and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-529
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-529-03	1 in 1 CARTON	09/20/2014
1		141 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	09/20/2014

Labeler - Arbonne International, LLC (021541164)