ICE COLD TOPICAL ANALGESIC GEL- menthol gel 
China Ningbo Shangge Cosmetic Technology Corp.

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 Topical Analgesic Gel

Active Ingredient                                   Purpose

Menthol 1.25%...........................Topical Analgesic

Uses

forthe temporary relief of minor aches and pains of muscles and joints.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Other information

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with 

When using this product do not

Consult a doctor and discontinue use if condition worsesn, persists for more than 1 week or tends to recur.

Directions

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

label image

ICE COLD TOPICAL ANALGESIC GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.84 mg  in 227 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-007-01237 mg in 1 BOTTLE; Type 0: Not a Combination Product05/24/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/24/2013
Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-007)

Revised: 11/2022
Document Id: edb156ce-6526-42fa-e053-2a95a90a4057
Set id: 50e7d221-d73a-4550-9a7e-8d33a3910629
Version: 3
Effective Time: 20221117
 
China Ningbo Shangge Cosmetic Technology Corp.