PERSONAL CARE- medicated body powder powder

Personal Care by

Drug Labeling and Warnings

Personal Care by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, Inc., Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                      Purpose
Menthol 0.15 percent                   External analgesic
Zinc Oxide 1.0 percent                     Skin protectant

PURPOSE

Uses     for the temporary relief of the pain and itch associated with:
- minor cuts - scrapes - sunburn - insect bites - prickly heat - rashes
- minor burns - minor skin irritation - dries the oozing of poison ivy, oak
and sumac.

WARNINGS

Warnings
For external use only
When using this product avoid contact with eyes.

ASK DOCTOR

Stop using and ask a doctor if
- condition worsens 
- symptoms do not get better within 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or
contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
adults and children 2 years and older, apply freely up to 3 or 4 times daily
- under 2 years: ask a doctor before using
- for best results, dry skin thoroughly before use.

INACTIVE INGREDIENT

Inactive ingredients
talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PERSONAL CARE 
medicated body powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-9090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	3 mg  in 2 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Oxide	20 mg  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Talc (UNII: 7SEV7J4R1U)
Acacia (UNII: 5C5403N26O)
Eucalyptol (UNII: RV6J6604TK)
Methyl Salicylate (UNII: LAV5U5022Y)
Salicylic Acid (UNII: O414PZ4LPZ)
Thymol (UNII: 3J50XA376E)
Zinc Stearate (UNII: H92E6QA4FV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-9090-1	283 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2009

Labeler - Personal Care Products, Inc. (603124298)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture