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ICE COLD Analgesic by MCure Health Solutions

Medically reviewed on December 7, 2017

Dosage form: cream
Ingredients: MENTHOL 2mg in 1g
Labeler: MCure Health Solutions
NDC Code: 52486-005

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 Gel

Drug Facts

Active ingredient

Menthol 2%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains in muscles and joints associated with:

• simple backache • strains • sprains • sports injuries • arthritis • 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

If pregnant or breast-feeding

• ask a health professional before use

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

ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alchohol, magnesium sulfate, sodium hydroxide, thymol, water

Package Labeling:

ICE COLD ANALGESIC 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIA 
CARBOXYPOLYMETHYLENE 
CUPRIC SULFATE 
FD&C BLUE NO. 1 
ISOPROPYL ALCOHOL 
MAGNESIUM SULFATE 
SODIUM HYDROXIDE 
THYMOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:52486-005-011 JAR in 1 BOX
1227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/05/2015
Labeler - MCure Health Solutions (053034873)

 
MCure Health Solutions

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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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