Health Smart Baby: Package Insert and Label Information

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%

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
(click image for full-size original)

HEALTH SMART BABY
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 (TALC) TALC 1 g in 1 g
Inactive Ingredients
Ingredient Name Strength
FRAGRANCE CLEAN ORC0600327 0.001 g in 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52862-010-13 57 g in 1 BOTTLE None
2 NDC:52862-010-14 113 g in 1 BOTTLE None
3 NDC:52862-010-15 397 g in 1 BOTTLE None
4 NDC:52862-010-16 624 g in 1 BOTTLE None
5 NDC:52862-010-17 680 g in 1 BOTTLE None
6 NDC:52862-010-18 737 g in 1 BOTTLE None
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 Operations
Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture (52862-010)

Revised: 08/2020 Home Smart Products

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