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Ice Cold Analgesic

Dosage form: gel
Ingredients: MENTHOL 2.27g in 227g
Labeler: Personal Care Products
NDC Code: 29500-9034

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.

Ice Cold analgesic



Active Ingredients:

Menthol 1%



Purpose

Topical analgesic



Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.



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 doctor if condition worsens, symptoms last more than  days or clear up and occur again within a few days, redness or irritation develops
If pregnant or breast feeding ask a health professional before use.




Directions

Clean affected area before applying product

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




Inactive ingredients carbomer, isopropyl alcohol, kathon CG, sodium hydroxide, thymol, water (aqua), FD and C blue no.1


Personal Care

Ice cold

analgesic gel

New wt. 8 oz. (227 g)

ICE COLD ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9034
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.27 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
SODIUM HYDROXIDE 
THYMOL 
WATER 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:29500-9034-6227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2011
Labeler - Personal Care Products (966155082)
Registrant - Personal Care Products (966155082)
Establishment
NameAddressID/FEIOperations
Ningbo Liyuan Daily Chemical Products Co Ltd530766098manufacture

Revised: 08/2011
 
Personal Care Products

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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