Personal Care Ice Cold

Dosage form: gel
Ingredients: MENTHOL 1g in 100g
Labeler: Personal Care Products, Inc.
NDC Code: 29500-2278

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.

Personal Care Ice Cold Analgesic

DRUG FACTS

Active ingredients                        Purpose

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

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

For external use only


 Do not use with other topical pain relievers

with heating pads or heating devices

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 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

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.

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

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

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)

PERSONAL CARE ICE COLD  
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2278
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
THYMOL 
WATER 
ISOPROPYL ALCOHOL 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:29500-2278-1227 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34806/04/2010
Labeler - Personal Care Products, Inc. (966155082)
Establishment
NameAddressID/FEIOperations
Ningbo Liyuan daily Chem. Products Co Ltd530766098manufacture

Revised: 08/2011
 
Personal Care Products, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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