HEALTH SMART BABY- talc powder

Health Smart Baby by

Drug Labeling and Warnings

Health Smart Baby by is a Otc medication manufactured, distributed, or labeled by Home Smart Products, 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

For Babies: Use after every bath and diaper change to make your baby’s skin soft and smooth. Helping to keep your baby happy and comfortable.

For Adults: Use after bath or shower to keep your skin fresh and comfortable. Helps eliminate friction to keep skin from becoming irritated.

WARNINGS

Warning

For external use only. Avoid contact with eyes discontinue if irritation developes.

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

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

DOSAGE & ADMINISTRATION

Directions

Apply product liberally, as often as necessary

STORAGE AND HANDLING

Storage

Store in a cool and dry place. Close tightly after use.

INACTIVE INGREDIENT

Inactive Ingredient

Fragrance

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Health Smart Baby Powder

NET WT. 14 OZ (397G)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTH SMART BABY 
talc powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U)	TALC	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52862-010-13	57 g in 1 BOTTLE
2	NDC: 52862-010-14	113 g in 1 BOTTLE
3	NDC: 52862-010-15	397 g in 1 BOTTLE
4	NDC: 52862-010-16	624 g in 1 BOTTLE
5	NDC: 52862-010-17	680 g in 1 BOTTLE
6	NDC: 52862-010-18	737 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	12/19/2012

Labeler - Home Smart Products (161872676)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52862-010)