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  5. Label Information: Leader Ice Blue Analgesic

FDA Label for Leader Ice Blue Analgesic

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND CONSULT A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 226.8 G JAR LABEL

Leader Ice Blue Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 - leader 01

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label - leader 01


* Please review the disclaimer below.