PAN AROMAS BABY- mineral oil oil 
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

Mineral Oil 99.9%

Purpose

Skin Protectant

Uses

Warnings

For External Use Only.

Keep out of the reach of children

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

Directions

Apply product liberally, as often as necessary.

Inactive Ingredient

Fragrance

PRINCIPAL DISPLAY PANEL

Pan Aromas Baby Oil

NET WT. 10 FL OZ (296 mL)

label

PAN AROMAS BABY 
mineral oil oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50346-005
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 99.9 mL  in 100 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50346-005-16 100 mL in 1 BOTTLE
2 NDC:50346-005-17 192 mL in 1 BOTTLE
3 NDC:50346-005-18 200 mL in 1 BOTTLE
4 NDC:50346-005-19 296 mL in 1 BOTTLE
5 NDC:50346-005-20 355 mL in 1 BOTTLE
6 NDC:50346-005-21 414 mL in 1 BOTTLE
7 NDC:50346-005-22 474 mL in 1 BOTTLE
8 NDC:50346-005-23 590 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 12/20/2012
Labeler - Pan Aromas LLC (078451131)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
Name Address ID/FEI Business Operations
Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(50346-005)

Revised: 12/2012
Document Id: a1ef7014-45b2-408e-8e99-952c0ffbcc27
Set id: cca5a149-01ed-41f8-9cb7-258b94ac94ab
Version: 1
Effective Time: 20121220
 
Pan Aromas LLC