NATURES CHOICE BABY- talc powder 
Unipack, 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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NATURES CHOICE BABY POWDER

Active Ingredient

Talc 99%

Purpose

Skin Protectant

Uses

It helps to absorb excess moisture, keeps the baby’s skin dry and soft for ultimate comfort.

Warnings

Directions

After changing diapers and after every bath dry baby’s skin thoroughly and apply liberally as needed.

Inactive Ingredient

Fragrance

Package/Label Principal Display Panel

Natures Choice Baby Powder

Velvety Soft

NET WT 22 OZ (624 g)

LABEL

NATURES CHOICE BABY 
talc powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC99 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-112-0550 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
2NDC:43749-112-06100 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
3NDC:43749-112-07113 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
4NDC:43749-112-09116 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
5NDC:43749-112-10368 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
6NDC:43749-112-11396 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
7NDC:43749-112-14424 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
8NDC:43749-112-15624 g in 1 BOTTLE; Type 0: Not a Combination Product06/07/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34706/07/2016
Labeler - Unipack, Inc. (009248480)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(43749-112)

Revised: 6/2016
Document Id: 34b44cbd-7562-481b-e054-00144ff8d46c
Set id: ba1ee906-1854-441c-b05d-dd6ca55b1a72
Version: 1
Effective Time: 20160613
 
Unipack, Inc.