ICE EXTERNAL ANALGESIC LEADER- menthol gel

Ice External Analgesic by

Drug Labeling and Warnings

Ice External Analgesic by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 2.0%

INDICATIONS & USAGE

Uses

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

WARNINGS

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. 

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

Purpose

Pain relieving gel.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

PRINCIPAL DISPLAY PANEL

Ice Gel External Analgesic.

INGREDIENTS AND APPEARANCE

ICE EXTERNAL ANALGESIC  LEADER
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-616
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	.02 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-616-34	227 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	12/01/2011

Labeler - Cardinal Health (097537435)