LEADER ICE BLUE  ANALGESIC- menthol, unspecified form gel 
Cardinal Health, 110 dba LEADER

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Leader Ice Blue Gel
Topical Analgesic

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?

1-866-567-8600

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*

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NET WT 8 OZ (226.8 g)

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label
LEADER ICE BLUE   ANALGESIC
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0260
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 (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
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0260-1226.8 g in 1 JAR; Type 0: Not a Combination Product05/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01705/31/2017
Labeler - Cardinal Health, 110 dba LEADER (063997360)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Garcoa, Inc.036464697MANUFACTURE(70000-0260)

Revised: 2/2024
Document Id: 19a1cc3c-5e5b-43f8-9377-cc97d7c60a55
Set id: 952e56ea-5cbc-4078-bd01-5d3b6864a5ce
Version: 3
Effective Time: 20240209
 
Cardinal Health, 110 dba LEADER