Leader Ice Blue Gel
FDA Label NDC 70000-0260

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, 110 Dba Leader for the product Leader Ice Blue (NDC 70000-0260). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and consult a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (226.8 g Jar Label)

* Please review the disclaimer below.