Your browser does not support JavaScript! PAN AROMAS BABY (TALC) POWDER [PAN AROMAS LLC]
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PAN AROMAS BABY (talc) powder
[Pan Aromas LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient

Talc 100%

Purpose

Skin Protectant

Uses

To help absorb excess moisture and keep your baby's skin dry and soft.

Warnings

For external use only.

Keep away from baby's nose and mouth. Close lid after use.

Keep out of the reach of children

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

Directions

After changing nappies and after every bath, dry baby's skin thoroughly and apply liberally as needed

Inactive Ingredient

Fragrance

PRINCIPAL DISPLAY PANEL

Pan Aromas Baby Powder

NET WT. 14 OZ (397g)

label

PAN AROMAS BABY 
talc powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50346-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TALC (TALC) TALC1 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:50346-004-1057 g in 1 BOTTLE
2NDC:50346-004-11113 g in 1 BOTTLE
3NDC:50346-004-12397 g in 1 BOTTLE
4NDC:50346-004-13624 g in 1 BOTTLE
5NDC:50346-004-14680 g in 1 BOTTLE
6NDC:50346-004-15737 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34712/19/2012
Labeler - Pan Aromas LLC (078451131)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(50346-004)

Revised: 12/2012
Document Id: e8f3c7ef-caed-42fc-bdc6-532544390ee8
Set id: 9b80ce99-f192-4b00-bbb2-1dfac539b41f
Version: 1
Effective Time: 20121219
 
Pan Aromas LLC

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