FDA.reportPublic FDA data

Baby

Manufacturer
Walgreen Company | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:42

Label at a glance#

ProductBaby
Active ingredientTALC
Label structure11 sections

Storage and handling

Storage Store in a cool, dry place.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Talc 100%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses
Keeps skin soft, fresh & comfortable.

WARNINGS SECTION

Warnings

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

SPL UNCLASSIFIED SECTION

Close tightly after use.

Do not use on broken skin.

Avoid contact with eyes.

Keep powder away from child’s face to avoid inhalation, which can cause breathing problems.

DOSAGE & ADMINISTRATION SECTION

Directions

Shake powder into your hand and smooth onto skin.

STORAGE AND HANDLING SECTION

Storage

Store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredient

Fragrance

SPL UNCLASSIFIED SECTION

Package/Label Principal Display Panel

Baby Powder

Keeps skin soft, fresh & comfortable

Clinically Tested

NET WT 4 OZ (113 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1233081talc 100 % Topical PowderPSN2
1233081talc 1 MG/MG Topical PowderSCD2
1233081talc 100 % Topical PowderSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0901-042025-01-30C16284748780-19d75b9d0-f78d-f424-e053-dadaa90a57ceBABY POWDER
0363-0901-152025-01-30C16284748780-19d75b9d0-f78d-f424-e053-dadaa90a57ceBABY POWDER
0363-0901-222025-01-30C16284748780-19d75b9d0-f78d-f424-e053-dadaa90a57ceBABY POWDER
0363-0901-042020-08-13C16284748780-19d75b9d0-f78d-f424-e053-dadaa90a57ceBABY POWDER
0363-0901-152020-08-13C16284748780-19d75b9d0-f78d-f424-e053-dadaa90a57ceBABY POWDER
0363-0901-222020-08-13C16284748780-19d75b9d0-f78d-f424-e053-dadaa90a57ceBABY POWDER
0363-0901-042020-01-31C16284748780-19d75b9d0-f78d-f424-e053-dadaa90a57ceBABY POWDER
0363-0901-152020-01-31C16284748780-19d75b9d0-f78d-f424-e053-dadaa90a57ceBABY POWDER
0363-0901-222020-01-31C16284748780-19d75b9d0-f78d-f424-e053-dadaa90a57ceBABY POWDER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0901-04Baby113 g in 1 BOTTLEPOWDER1132
0363-0901-15Baby425 g in 1 BOTTLEPOWDER4252
0363-0901-22Baby623 g in 1 BOTTLEPOWDER6232

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0901BABY (TALC) POWDER [WALGREEN COMPANY]2Legacy NDC, 3 package rows20200814_eead56df-4ddb-4b0e-834f-241a7dba2791.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TALCACTIVE INGREDIENT7SEV7J4R1U1
TALCACTIVE MOIETY7SEV7J4R1U1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-09010363-0901-04, 0363-0901-15, 0363-0901-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TALC7SEV7J4R1UACTIB
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT

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
acc1c925-ee1b-71ca-e053-2a95a90a1544eead56df-4ddb-4b0e-834f-241a7dba27912020-08-13WarningsExact identifier
spl id: acc1c925-ee1b-71ca-e053-2a95a90a1544
spl set id: eead56df-4ddb-4b0e-834f-241a7dba2791

Reported adverse events (FAERS/openFDA)#

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