FDA.reportPublic FDA data

Babys Butt Aid

Manufacturer
American Consumer Products Corp
Effective date
2021-03-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:56

Label at a glance#

ProductBabys Butt Aid
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

Uses • Helps treat and prevent diaper rash • Prevents chafed skin due to diaper rash and helps seal out wetness.

Dosage and administration

Directions: • Change wet and soiled diapers promptly. • Cleanse the diaper area and allow to dry. • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide 16%

Purpose

OTC - PURPOSE SECTION

Purpose

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Uses • Helps treat and prevent diaper rash • Prevents chafed skin due to diaper rash and helps seal out wetness.

Warnings

WARNINGS SECTION

Warnings

For external use only.

When using this product

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes.

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

Keep out of reach of children

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

Directions: • Change wet and soiled diapers promptly. • Cleanse the diaper area and allow to dry. • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Other information

SPL UNCLASSIFIED SECTION

Other information: store at 20° to 27°C (68° to 80.6°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: petrolatum, mineral oil, hydroxyethyl cellulose, pentaerythrityl tetrastearate, microcrystalline wax, propylparaben, fragrance.

Distributed By:

SPL UNCLASSIFIED SECTION

Distributed By: American Consumer Products Corp

Vernon, CA 90058

MADE IN CHINA

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Babys Butt AidBabys Butt AidBabys Butt AidBabys Butt Aid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091950Baby's Butt Aid 16 % Topical OintmentPSN2
708071zinc oxide 16 % Topical OintmentPSN2
1091950zinc oxide 0.16 MG/MG Topical Ointment [Baby's Butt Aid]SBD2
708071zinc oxide 0.16 MG/MG Topical OintmentSCD2
1091950Baby's Butt Aid 0.16 MG/MG Topical OintmentSY2
1091950Baby's Butt Aid 16 % Topical OintmentSY2
708071zinc oxide 16 % Topical OintmentSY2
708071ZNO 0.16 MG/MG Topical OintmentSY2
1091950ZNO 0.16 MG/MG Topical Ointment [Baby's Butt Aid]SY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72197-039-022023-01-30C16284748780-1f386c64a-05a6-0266-e053-dadaa90a7c1aBabys Butt Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72197-039-02Babys Butt Aid56 g in 1 TUBEOINTMENT562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72197-039BABYS BUTT AID (ZINC OXIDE) OINTMENT [AMERICAN CONSUMER PRODUCTS CORP]2Legacy NDC, 1 package rows20210312_b8bc92f1-8524-32db-e053-2a95a90a1f46.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72197-03972197-039-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTAERYTHRITYL TETRASTEARATEW9Q3DZS0EGIACT
ZINC OXIDESOI2LOH54ZACTIB
MINERAL OILT5L8T28FGPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PETROLATUM4T6H12BN9UIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
bcd44a8e-570b-2304-e053-2a95a90ae923b8bc92f1-8524-32db-e053-2a95a90a1f462021-03-10WarningsExact identifier
spl id: bcd44a8e-570b-2304-e053-2a95a90ae923
spl set id: b8bc92f1-8524-32db-e053-2a95a90a1f46

Reported adverse events (FAERS/openFDA)#

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