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%


Skin protectant.


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.


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


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)
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
# 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)
Name Address ID/FEI Operations
Kim Chemicals Private Limited 915182067 manufacture

Revised: 12/2011 Vini Health & Beauty Inc provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

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