PAN AROMAS BABY- talc powder 
Pan Aromas LLC

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:50346-004
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC 1 g  in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50346-004-10 57 g in 1 BOTTLE
2 NDC:50346-004-11 113 g in 1 BOTTLE
3 NDC:50346-004-12 397 g in 1 BOTTLE
4 NDC:50346-004-13 624 g in 1 BOTTLE
5 NDC:50346-004-14 680 g in 1 BOTTLE
6 NDC:50346-004-15 737 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part347 12/19/2012
Labeler - Pan Aromas LLC (078451131)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
Name Address ID/FEI Business Operations
Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(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