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

ABC Arbonne Baby Care Diaper Rash by

Drug Labeling and Warnings

ABC Arbonne Baby Care Diaper Rash 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

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

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: 42508-331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-331-03	1 in 1 CARTON	06/30/2023
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 DRUG	M016	06/30/2023

Labeler - Arbonne International, LLC (961643454)