Your browser does not support JavaScript! PAN AROMAS BABY (MINERAL OIL) OIL [PAN AROMAS LLC]
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PAN AROMAS BABY (mineral oil) oil
[Pan Aromas LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph 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

Mineral Oil 99.9%

Purpose

Skin Protectant

Uses

  • Helps moisturize delicate skin and helps prevent chafing.
  • Use after shower or bath for superior moisturizing, helping skin stay soft and smooth.
  • Also used as make-up remover from delicate skin.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:50346-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL99.9 mL  in 100 mL
Packaging
#Item CodePackage Description
1NDC:50346-005-16100 mL in 1 BOTTLE
2NDC:50346-005-17192 mL in 1 BOTTLE
3NDC:50346-005-18200 mL in 1 BOTTLE
4NDC:50346-005-19296 mL in 1 BOTTLE
5NDC:50346-005-20355 mL in 1 BOTTLE
6NDC:50346-005-21414 mL in 1 BOTTLE
7NDC:50346-005-22474 mL in 1 BOTTLE
8NDC:50346-005-23590 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/20/2012
Labeler - Pan Aromas LLC (078451131)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(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

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