SOF SKIN BABY POWDER- talc powder
Viny Health and 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.

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Active Ingredient

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.

Package Label

Package label

SOF SKIN BABY POWDER
talc powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76436-135
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U)	TALC	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76436-135-24	675 g in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2007	10/17/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	03/27/2007	10/17/2017

Labeler - Viny Health and Beauty Inc (963374942)

Revised: 10/2017

Document Id: 5bc0a216-98cb-77ea-e053-2a91aa0a27c7

Set id: 6bbbb95e-6cb5-4bb6-a5ec-7cf9ac3f9103

Version: 6

Effective Time: 20171017

Viny Health and Beauty Inc