Ice External Analgesic Leader

Dosage form: gel
Ingredients: Menthol .02g in 100g
Labeler: Cardinal Health
NDC Code: 37205-616

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.

Drug Facts

Menthol 2.0%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:  simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only.  When using this product: avoid contact with the eyes, do not bandage tightly, do not apply to wounds or damaged skin, and do not use with heating pads of other heating devices. Stop use and ask doctor if:  condition gets worse, symptoms last more than 7 days, or symptoms clear up and occur again in a few days. 

Directions

Adults and children 2 years of age and older:  apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age: do not use, consult a doctor.

Inactive ingredients

Aloe Barbadensis Leaf Juice, SD Alcohol 40, Propylene Glycol, Glycerin, Simethicone, Tocopheryl Acetate, Triethanolamine, Carbomer, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium Cocoamphodipropionate, Disodium EDTA.

Purpose

Pain relieving gel.


Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ice Gel External Analgesic.


ICE EXTERNAL ANALGESIC  LEADER
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-616
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol.02 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Ammonia 
Carbomer 934 
Cupric Sulfate 
FD&C BLUE NO. 1 
Isopropyl Alcohol 
Magnesium Sulfate 
Sodium Hydroxide 
Thymol 
Water 
Packaging
#Item CodePackage Description
1NDC:37205-616-34227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34812/01/2011
Labeler - Cardinal Health (097537435)

Revised: 01/2011
 
Cardinal Health

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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