FDA.reportPublic FDA data

Pan Aromas Baby

Manufacturer
Pan Aromas LLC | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2012-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:34:04

Label at a glance#

ProductPan Aromas Baby
Active ingredientTALC
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Talc 100%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

To help absorb excess moisture and keep your baby's skin dry and soft.

WARNINGS SECTION

Warnings

For external use only.

Keep away from baby's nose and mouth. Close lid after use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Children if swallowed get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

After changing nappies and after every bath, dry baby's skin thoroughly and apply liberally as needed

INACTIVE INGREDIENT SECTION

Inactive Ingredient

Fragrance

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Pan Aromas Baby Powder

NET WT. 14 OZ (397g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1233081talc 100 % Topical PowderPSN1
1233081talc 1 MG/MG Topical PowderSCD1
1233081talc 100 % Topical PowderSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50346-004-102020-01-31C16284748780-19d75b9d0-943f-f424-e053-dadaa90a57ce9b80ce99-f192-4b00-bbb2-1dfac539b41f
50346-004-112020-01-31C16284748780-19d75b9d0-943f-f424-e053-dadaa90a57ce9b80ce99-f192-4b00-bbb2-1dfac539b41f
50346-004-122020-01-31C16284748780-19d75b9d0-943f-f424-e053-dadaa90a57ce9b80ce99-f192-4b00-bbb2-1dfac539b41f
50346-004-132020-01-31C16284748780-19d75b9d0-943f-f424-e053-dadaa90a57ce9b80ce99-f192-4b00-bbb2-1dfac539b41f
50346-004-142020-01-31C16284748780-19d75b9d0-943f-f424-e053-dadaa90a57ce9b80ce99-f192-4b00-bbb2-1dfac539b41f
50346-004-152020-01-31C16284748780-19d75b9d0-943f-f424-e053-dadaa90a57ce9b80ce99-f192-4b00-bbb2-1dfac539b41f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50346-004-10Pan Aromas Baby57 g in 1 BOTTLEPOWDER571
50346-004-11Pan Aromas Baby113 g in 1 BOTTLEPOWDER1131
50346-004-12Pan Aromas Baby397 g in 1 BOTTLEPOWDER3971
50346-004-13Pan Aromas Baby624 g in 1 BOTTLEPOWDER6241
50346-004-14Pan Aromas Baby680 g in 1 BOTTLEPOWDER6801
50346-004-15Pan Aromas Baby737 g in 1 BOTTLEPOWDER7371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50346-004PAN AROMAS BABY (TALC) POWDER [PAN AROMAS LLC]1Legacy NDC, 6 package rows20121222_9b80ce99-f192-4b00-bbb2-1dfac539b41f.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 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50346-00450346-004-10, 50346-004-11, 50346-004-12, 50346-004-13, 50346-004-14, 50346-004-15

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
TALC7SEV7J4R1UACTIB

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
e8f3c7ef-caed-42fc-bdc6-532544390ee89b80ce99-f192-4b00-bbb2-1dfac539b41f2012-12-19WarningsExact identifier
spl id: e8f3c7ef-caed-42fc-bdc6-532544390ee8
spl set id: 9b80ce99-f192-4b00-bbb2-1dfac539b41f

Reported adverse events (FAERS/openFDA)#

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