Abc Arbonne Baby Care Diaper Rash Cream
FDA Label NDC 42508-331

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Arbonne International, Llc for the product Abc Arbonne Baby Care Diaper Rash (NDC 42508-331). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by
Arbonne International, LLC
Greenwood, IN 46143 USA

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

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (141 g Tube Carton)

* Please review the disclaimer below.