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  5. Label Information: K2 Cold Therapy

FDA Label for K2 Cold Therapy

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. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

K2 Cold Therapy Product Label

The following document was submitted to the FDA by the labeler of this product The Podiatree 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 ingrdient:

Menthol 10%


Otc - Purpose



PURPOSE

TOPICAL ANALGESIC


Indications & Usage



TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

  • ARTHRITIS
  • SIMPLE BACKACHE
  • MUSCLE STRAINS
  • SPRAINS

Warnings



For external use only.

Flammable; Keep away from fire, sparks and heated surfaces


Otc - When Using



  • Use only as directed
  • Do not bandage tighlty or use with a heating pad
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged, broken, or irritated skin.

Otc - Stop Use



  • Condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and reoccur 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.


Dosage & Administration



  • Adults and children 12 years of age and older: Apply a thin layer over the affected area not more than 3 to 4 times daily.
  • Children 12 years of age or younger: Consult a doctor.
  • Close cap tightly after use.

Storage And Handling



Store at controlled room temperature. Do not shake bottle with cap removed.


Inactive Ingredient



Aloe Barbadensis Leaf Juice, Camphor, Eucalyptus Globulus Leaf Oil, FD&C Blue #1, FD&C Yellow #5, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Oil, SD 40 Alcohol (5%) Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Sesquioleate, Steareth 2, Steareth 20, Urea, Vitis Vinifera (Grape) Seed Extract, Water (Purified)


Otc - Questions



1.855.763.8733 or visit us at www.thepodiatreecompany.com


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