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  5. Label Information: Cold Therapy Pain Relief

FDA Label for Cold Therapy Pain Relief

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 A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL – 74 ML BOTTLE LABEL
    13. PRINCIPAL DISPLAY PANEL – 89 ML TUBE LABEL

Cold Therapy Pain Relief 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.

Active Ingredient



Menthol 4%


Purpose



Topical Analgesic


Uses



Temporarily relieves minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



For external use only.

Flammable: Keep away from excessive heat or open flame.


When Using This Product



  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop Use And Ask A Doctor If



  • you experience pain, swelling or blistering oi the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

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 older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water

Other Information



  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight

Inactive Ingredients



Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguanensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.


Principal Display Panel – 74 Ml Bottle Label



Walgreens

Compare to the active ingredient
in Biofreeze® Roll-On††

WALGREENS PHARMACIST RECOMMENDED

Cold Therapy
Pain Relief

MENTHOL 4% / TOPICAL ANALGESIC

Roll On

Cooling Pain Relief

Principal Display Panel – 89 Ml Tube Label



Walgreens

Compare to the active
ingredient in Biofreeze® Gel††

WALGREENS PHARMACIST RECOMMENDED

Cold
Therapy
Pain Relief
Gel

MENTHOL 4% / TOPICAL ANALGESIC

Cooling Pain Relief

* Please review the disclaimer below.