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  5. Label Information: Cool N Heat Patch For Arm, Neck And Leg Extra Strength

FDA Label for Cool N Heat Patch For Arm, Neck And Leg Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. OTC - QUESTIONS

Cool N Heat Patch For Arm, Neck And Leg Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Co.. 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.

Otc - Active Ingredient



Active ingredient

Menthol 5%


Otc - Purpose



Purpose

Topical Analgesic


Indications & Usage



Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings



Warnings

  • For external use only
  • If pregnant or breast-feeding, ask a health professional before use.

Otc - When Using



When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions
adults and children 12 years of age and older

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • apply one patch to affected area
  • repeat as necessary, but no more than 4 times daily

    • children under 12 years of age consult a doctor


Storage And Handling



Other information

  • store at room temperature

Inactive Ingredient



Inactive ingredients

aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, castor oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate


Otc - Questions



Questions or comments? 1-800-WALGREENS (1-800-925-4733)


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