PERSONAL CARE ICE COLD- menthol gel

Personal Care Ice Cold by

Drug Labeling and Warnings

Personal Care Ice Cold by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, Inc., Ningbo Liyuan daily Chem. Products Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active ingredients                        Purpose

Menthol (1%)................................Topical Analgesic

PURPOSE

Uses-For the temporary relief of minor aches and pains in muscles and joints associated with:

simple backache

sports injuries

strains

arthritis

sprains

bruises

WARNINGS

warnings

For external use only

DO NOT USE

 Do not use with other topical pain relievers

with heating pads or heating devices

WHEN USING

When using this product

do not use in or near eyes

do not apply to wounds or damaged skin

do not bandage tightly

STOP USE

Stop use and ask a doctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

redness or irritation develops

INDICATIONS & USAGE

For the temporary relief of aches and pains in muscles and joints associated with

simple backache

sports injuries

strains

arthritis

sprains

bruises

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

if swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions

Clean affected area before applying product

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

INACTIVE INGREDIENT

Inactive Ingredients: carbomer, isopropyl alcohol, kathon CG, sodium hydroxide, thymol, water(aqua), FDandC blue no 1

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

DISTRIBUTED BY PERSONAL CARE PRODUCTS INC

Bingham Farms MI 48025-2463 USA

Made in China

Personal Care Ice Cold Analgesic Gel

Net wt. 8oz (227g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PERSONAL CARE ICE COLD  
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-2278
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
THYMOL (UNII: 3J50XA376E)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-2278-1	227 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	06/04/2010

Labeler - Personal Care Products, Inc. (966155082)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Liyuan daily Chem. Products Co Ltd		530766098	manufacture