PAN AROMAS BABY- talc powder

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

Talc 100%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

To help absorb excess moisture and keep your baby's skin dry and soft.

WARNINGS

Warnings

For external use only.

Keep away from baby's nose and mouth. Close lid after use.

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

After changing nappies and after every bath, dry baby's skin thoroughly and apply liberally as needed

INACTIVE INGREDIENT

Inactive Ingredient

Fragrance

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Pan Aromas Baby Powder

NET WT. 14 OZ (397g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAN AROMAS BABY 
talc powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50346-004
Route of Administration	TOPICAL

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)