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Ice Cold Topical Analgesic Gel

Medically reviewed on June 4, 2018

Dosage form: gel
Ingredients: MENTHOL 2.84mg in 227mg
Labeler: Greenbrier International, Inc.
NDC Code: 33992-3007

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.

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

  • store at 20oC to 25oC (68o to 77oF)

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with 

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

When using this product do not

  • heat
  • microwafe
  • add to hot water or any container where healing water may cause splattering and result in burns
  • use in eyes or directly on mucous membranes
  • take by mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

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

Directions

  • see important warnings under "When using this product"
  • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: consult a physician.

Inactive Ingredients

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

ICE COLD TOPICAL ANALGESIC GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-3007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.84 mg  in 227 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
ALCOHOL 
ISOPROPYL ALCOHOL 
CAMPHOR (NATURAL) 
FD&C BLUE NO. 1 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:33992-3007-1237 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/24/2013
Labeler - Greenbrier International, Inc. (610322518)
Establishment
NameAddressID/FEIOperations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(33992-3007)

 
Greenbrier International, Inc.

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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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