PAN AROMAS BABY- mineral oil oil

Pan Aromas Baby by

Drug Labeling and Warnings

Pan Aromas Baby by is a Otc medication manufactured, distributed, or labeled by Pan Aromas LLC, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Mineral Oil 99.9%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

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

Warnings

For External Use Only.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

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

DOSAGE & ADMINISTRATION

Directions

Apply product liberally, as often as necessary.

INACTIVE INGREDIENT

Inactive Ingredient

Fragrance

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Pan Aromas Baby Oil

NET WT. 10 FL OZ (296 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAN AROMAS BABY 
mineral oil oil

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

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)