PURE CORNSTARCH BABY- corn starch powder

Pure Cornstarch Baby by

Drug Labeling and Warnings

Pure Cornstarch 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

Corn Starch (Zea Mays) 99%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

• gently absorbs excess moisture for soft, dry skin.
• helps protect against irritating friction, leaving your skin feeling cool and comfortable.

WARNINGS

Warnings

Avoid contact with eyes.

For external use only.

Do not use on broken skin.

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

Close tightly after use.

KEEP OUT OF REACH OF CHILDREN

Keep this product out of reach of children.

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 ingredients

Tricalcium Phosphate, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E).

SPL UNCLASSIFIED SECTION

Package/Label Principal Display Panel

Pure Cornstarch Baby Powder

Gently absorbs excess moisture for soft, dry skin

Clinically Tested

NET WT 15 OZ (425 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE CORNSTARCH BABY 
corn starch powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0911
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STARCH, CORN (UNII: O8232NY3SJ) (STARCH, CORN - UNII:O8232NY3SJ)	STARCH, CORN	99 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0911-15	425 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	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(0363-0911)