BABY- talc powder 
Walgreen Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BABY POWDER

Active ingredient

Talc 100%

Purpose

Skin Protectant

Uses
Keeps skin soft, fresh & comfortable.

Warnings

For external use only.

Keep out of reach of children

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.

Directions

Shake powder into your hand and smooth onto skin.

Storage

Store in a cool, dry place.

Inactive ingredient

Fragrance

Package/Label Principal Display Panel

Baby Powder

Keeps skin soft, fresh & comfortable

Clinically Tested

NET WT 4 OZ (113 g)

label

BABY 
talc powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0901
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC100 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.1 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0901-04113 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
2NDC:0363-0901-15425 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
3NDC:0363-0901-22623 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34707/17/2014
Labeler - Walgreen Company (008965063)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(0363-0901)

Revised: 8/2020
Document Id: acc1c925-ee1b-71ca-e053-2a95a90a1544
Set id: eead56df-4ddb-4b0e-834f-241a7dba2791
Version: 2
Effective Time: 20200813
 
Walgreen Company