Baby by Walgreen Company / Jell Pharmaceuticals Pvt. Ltd. BABY- talc powder

Baby by

Drug Labeling and Warnings

Baby by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Talc 100%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses
Keeps skin soft, fresh & comfortable.

WARNINGS

Warnings

For external use only.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Shake powder into your hand and smooth onto skin.

STORAGE AND HANDLING

Storage

Store in a cool, dry place.

INACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY 
talc powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U)	TALC	100 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0901-04	113 g in 1 BOTTLE
2	NDC: 0363-0901-15	425 g in 1 BOTTLE
3	NDC: 0363-0901-22	623 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	07/17/2014

Labeler - Walgreen Company (008965063)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(0363-0901)