FDA.reportPublic FDA data

ABC Arbonne Baby Care Diaper Rash

Manufacturer
Arbonne International, LLC
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:36:18

Label at a glance#

ProductABC Arbonne Baby Care Diaper Rash
Active ingredientDIMETHICONE, ZINC OXIDE
Label structure11 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect from wetness

Dosage and administration

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

Storage and handling

Store between 20°C–25°C/68°F–77°F

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%
Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect from wetness

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • Store between 20°C–25°C/68°F–77°F

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ABC
ARBONNE BABY CARE ®

DIAPER RASH CREAM

Net wt. 5 oz./141 g

ABC Diaper Rash CreamABC Diaper Rash Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637565dimethicone 1 % / zinc oxide 12 % Topical CreamPSN2
637565dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical CreamSCD2
637565dimethicone 1 % / zinc oxide 12 % Topical CreamSY2
637565dimethicone 10 MG/ML / ZNO 120 MG/ML Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42508-331-03ABC Arbonne Baby Care Diaper Rash141 g in 1 TUBECREAM1412
42508-331-03ABC Arbonne Baby Care Diaper Rash1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42508-331ABC ARBONNE BABY CARE DIAPER RASH (DIMETHICONE AND ZINC OXIDE) CREAM [ARBONNE INTERNATIONAL, LLC]2Current NDC, 2 package rows20241109_dd1d8198-bb9d-4508-a971-ae3bc624cdd1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42508-33142508-331-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
CHLORPHENESINI670DAL4SZIACT
CARNAUBA WAXR12CBM0EIZIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATED21K655H52IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
SUNFLOWER OIL UNSAPONIFIABLEST7ZE2WA4MBIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM STEARATEQU7E2XA9TGIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABC Arbonne Baby Care Diaper RashDIMETHICONE AND ZINC OXIDEArbonne International, LLCdd1d8198-bb9d-4508-a971-ae3bc624cdd12024-11-08WarningsExact identifier
ndc (package): 42508-331-03
ndc (product): 42508-331
ndc11 (package): 42508033103
spl id: 266ee9ae-7f66-26d9-e063-6394a90a851e
spl set id: dd1d8198-bb9d-4508-a971-ae3bc624cdd1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.