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  5. Label Information: Kool Comfort

FDA Label for Kool Comfort

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. OTHER

Kool Comfort Product Label

The following document was submitted to the FDA by the labeler of this product Dee Cee Laboratories, 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 ingredientMenthol 2.5%

Otc - Purpose



PurposeCooling Pain relief

Uses



For the temporary relief of minor aches and pains of muscles and joints associated with · simple backache · arthritis ·strains · bruises · sprains

Warnings



For external use only.FlammableKeep away from excessive heat or open flame.

Otc - Ask Doctor



Ask a doctor before use if you have
  • sensitive skin

Otc - When Using



When using this product
  • avoid contact with the eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not use with other ointments, creams, sprays or liniments
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage
  • wash hands after use with cool water
  • do not use with heating pad or heating devices

Otc - Stop Use



Stop use and ask 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 breast-feeding, 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 right away.

Directions



  • Adults and children 2 years of age and over:  apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age:  Consult a physician.

Other Information



Store in a cool dry place with lid tightly closed.

Inactive Ingredients



Carbopol 934, FD&C blue #1, esi-cryll ll, herbal extract (ILEX paraguariensis), isopropyl alcohol, neutrol TE, phenonip, and purified water.

Other



Lot. No. & Exp. Date:  See label or bottom of container.Manufactured for:Dee Cee Laboratories Inc., 304 Dee Cee Ct., White House, TN  37188

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