HEALTH SMART BABY- talc powder 
Home Smart Products

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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Active Ingredient

Talc 100%

Purpose

Skin Protectant

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.

Warning

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

Keep Out of Reach of Children

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

Directions

Apply product liberally, as often as necessary

Storage

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

Inactive Ingredient

Fragrance

PRINCIPAL DISPLAY PANEL

Health Smart Baby Powder

NET WT. 14 OZ (397G)

label

HEALTH SMART BABY 
talc powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52862-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TALC (TALC) TALC1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52862-010-1357 g in 1 BOTTLE
2NDC:52862-010-14113 g in 1 BOTTLE
3NDC:52862-010-15397 g in 1 BOTTLE
4NDC:52862-010-16624 g in 1 BOTTLE
5NDC:52862-010-17680 g in 1 BOTTLE
6NDC:52862-010-18737 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34712/19/2012
Labeler - Home Smart Products (161872676)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-010)

Revised: 12/2012
Document Id: aa30f062-3187-456e-bb83-fe75d0d4f969
Set id: 404ca135-e7e4-4ac0-8ff0-4ddfb1cccb0a
Version: 1
Effective Time: 20121219
 
Home Smart Products