LEADER ICE BLUE ANALGESIC- menthol, unspecified form gel

Leader Ice Blue by

Drug Labeling and Warnings

Leader Ice Blue by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba LEADER, Garcoa, Inc., SV Labs Toronto Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

Menthol 2%

Purpose

Topical Analgesic

Uses

• ♦ temporarily relieves minor aches and pains of muscles and joints associated with
  • ♦ simple backache
  • ♦ arthritis
  • ♦ strains
  • ♦ bruises
  • ♦ sprains
• ♦ provides cooling penetrating relief

Warnings

For external use only

Do not use

• ♦ do not use with other topical pain relievers
• ♦ do not use with heating pads or other heating devices

When using this product

• ♦ avoid contact with the eyes
• ♦ do not bandage tightly
• ♦ do not apply to wounds or damaged skin

Stop use and consult a doctor if

• ♦ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breastfeeding, ask a health professional before use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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
• ♦ children under 2 years of age: do not use, consult a doctor

Other information

• ♦ do not freeze
• ♦ store at controlled room temperature 20 degrees to 25 degrees C, in a tightly closed container
• ♦ store in a cool place
• ♦ do not use, pour, spill or store near heat or open flame

Inactive ingredients

Ammonium Hydroxide, Blue 1, Carbomer, Copper Sulfate, Isopropyl Alcohol, Magnesium Sulfate, Sodium Hydroxide, Thymol, Water.

Questions or comments?

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DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

LEADER

NDC: 70000-0260-1

Ice Blue
Gel
Menthol 2.0%

Pain Relief Gel

Cooling
Greaseless

COMPARE TO
MINERAL ICE®
active ingredient*

100% Money
Back Guarantee

NET WT 8 OZ (226.8 g)

INGREDIENTS AND APPEARANCE

LEADER ICE BLUE   ANALGESIC
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
THYMOL (UNII: 3J50XA376E)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0260-1	226.8 g in 1 JAR; Type 0: Not a Combination Product	05/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/31/2017

Labeler - Cardinal Health (097537435)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(70000-0260)