ICE COLD ANALGESIC - menthol gel 
Personal Care Products

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.

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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

label


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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.27 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
THYMOL (UNII: 3J50XA376E)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Ningbo Liyuan Daily Chemical Products Co Ltd530766098manufacture

Revised: 8/2011
Document Id: ce7d5be7-57b3-41d3-a591-5483cab4fbf9
Set id: c52d4d06-b8df-479c-ab4b-dce88ae49c9d
Version: 3
Effective Time: 20110826
 
Personal Care Products