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  5. Label Information: Cool Heat

FDA Label for Cool Heat

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 - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cool Heat Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp Inc. 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 ingredients

Menthol                 10%

Methyl salicylate    30%


Otc - Purpose



Purpose

Topical analgesic


Indications & Usage



Uses

temporarily relieves minor pain associated with:

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

Warnings



Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor 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 or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin

Otc - Stop Use



When using this product

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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health care professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

If case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

Adults and Children over 12 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but not more than 4 times daily

    • Children 12 years or younger: ask a doctor


Inactive Ingredient



Inactive ingredients

carbomer, cetyl esters, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water.


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL
EXTRA STRENGTH
COOL HEAT PAIN RELIEVING CREAM
NET WT 1.25 OZ (35 g)

label of cool heat - cool heat 01

label of cool heat - cool heat 01


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