Sof Skin Baby Powder: Package Insert and Label Information

SOF SKIN BABY POWDER — talc powder
Vini Health & Beauty Inc

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.


Talc 100%

Purpose

Skin protectant.

Uses

It helps baby’s delicate skin from irritation and keep baby cool and comfortable.

Keep Out of Reach of Children

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

Warning

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

Directions

Apply product liberally, as often as necessary

Inactive Ingredient

Only Fragrance is present. No other inactive ingredients present.

Product Label



package label baby powder
(click image for full-size original)
SOF SKIN BABY POWDER
talc powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76436-135
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Talc (Talc) Talc 1 g in 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76436-135-24 675 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 03/27/2007
Labeler — Vini Health & Beauty Inc (963374942)
Establishment
Name Address ID/FEI Operations
Kim Chemicals Private Limited 915182067 manufacture

Revised: 12/2011 Vini Health & Beauty Inc

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