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NDC 70000-0260-01 Leader Ice Blue 20 mg/g Details

Leader Ice Blue 20 mg/g

Leader Ice Blue is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	70000-0260
Product ID	70000-0260_151e8370-02bc-48ac-bda5-3b951ac4322c
Associated GPIs	90070060004010
GCN Sequence Number	031061
GCN Sequence Number Description	menthol GEL (GRAM) 2 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	48059
HICL Sequence Number	002608
HICL Sequence Number Description	MENTHOL
Brand/Generic	Generic
Proprietary Name	Leader Ice Blue
Proprietary Name Suffix	Analgesic
Non-Proprietary Name	Menthol, Unspecified Form
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/g
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	Cardinal Health, 110 dba LEADER
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0260-01 (70000026001)

Pricing Information
NDC Package Code	70000-0260-1
Billing NDC	70000026001
Package	226.8 g in 1 JAR (70000-0260-1)
Marketing Start Date	2017-05-31
NDC Exclude Flag	N
Price Per Unit	0.01251
Pricing Unit	GM
Effective Date	2023-08-23
NDC Description	ICE BLUE 2% GEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 952e56ea-5cbc-4078-bd01-5d3b6864a5ce Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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)

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

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

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

Ingredient Name	Strength
Inactive Ingredients
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
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

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

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

Labeler - Cardinal Health, 110 dba LEADER (063997360)

Registrant - Garcoa, Inc. (036464697)

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

Revised: 6/2021

Document Id: 151e8370-02bc-48ac-bda5-3b951ac4322c

Set id: 952e56ea-5cbc-4078-bd01-5d3b6864a5ce

Version: 2

Effective Time: 20210625

Search by Drug Name or NDC

NDC 70000-0260-01 Leader Ice Blue 20 mg/g Details

Leader Ice Blue 20 mg/g

Product Information

Package

Package Images

NDC 70000-0260-01 (70000026001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 952e56ea-5cbc-4078-bd01-5d3b6864a5ce Details

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and consult a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

INGREDIENTS AND APPEARANCE

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