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.


Active Ingredient

Talc 100%


Skin Protectant


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.


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.


Apply product liberally, as often as necessary


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

Inactive Ingredient



Health Smart Baby Powder

NET WT. 14 OZ (397G)


talc powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52862-010
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC 1 g  in 1 g
# 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)
Name Address ID/FEI Business Operations
Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(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