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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50346-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	99.9 mL in 100 mL

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/20/2012

Labeler - Pan Aromas LLC (078451131)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(50346-005)