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  5. Label Information: Cold Therapy

FDA Label for Cold Therapy

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS:
    5. WHEN USING THIS PRODUCT:
    6. STOP USE AND ASK DOCTOR IF:
    7. IF PREGNANT OR BREAST FEEDING:
    8. KEEP OUT OF REACH OF CHILDREN:
    9. DIRECTIONS:
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS:
    12. PDP

Cold Therapy Product Label

The following document was submitted to the FDA by the labeler of this product Ahc Ventures Corp Dba Cryoderm. 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.

Active Ingredient



Menthol USP 10.0%


Purpose



Pain Reliever


Uses



Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises

Warnings:



For external use only


When Using This Product:



Use only as directed. Do not bandage or use a heating pad or device. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use with other ointment, creams, sprays or liniments. After applying wash hands thoroughly with cool water


Stop Use And Ask Doctor If:



Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritation develops


If Pregnant Or Breast Feeding:



Ask a health professional before use


Keep Out Of Reach Of Children:



In case of accidental ingestion get medical help or contact a Poison Control Center immediately


Directions:



Adults and children 2 years and older:
Apply directly onto afected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more than 4 times daily.
Children under 2 years of age: Consult a Physician


Other Information



Store in a cool dry place with lid or cap closed tightly

Flammable: Keep away from excessive heat or open flame


Inactive Ingredients:



Acrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine


* Please review the disclaimer below.