ICE EXTERNAL ANALGESIC LEADER- menthol gel 
Cardinal Health

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.

Jar image


ICE EXTERNAL ANALGESIC  LEADER
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-616
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol.02 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Ammonia (UNII: 5138Q19F1X)  
Carbomer 934 (UNII: Z135WT9208)  
Cupric Sulfate (UNII: LRX7AJ16DT)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Isopropyl Alcohol (UNII: ND2M416302)  
Magnesium Sulfate (UNII: DE08037SAB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Thymol (UNII: 3J50XA376E)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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: 1/2011
Document Id: 217355e0-291c-4ebe-b7ef-edc1b8c113f0
Set id: 0bece234-a67c-40d8-b51f-bfe7aaee9cd0
Version: 2
Effective Time: 20110111
 
Cardinal Health