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  5. Label Information: Cold And Hot Pain Relief Sleeve

FDA Label for Cold And Hot Pain Relief Sleeve

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. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABEL

Cold And Hot Pain Relief Sleeve Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, 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.

Active Ingredient



Menthol 16%


Purpose



Topical analgesic


Uses



Temporarily relieves minor pain associated with arthritis, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.


Warnings



For external use only


When Using This Product



  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin

Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Adults and children over 12 years

  • Clean and dry affected area.
  • Cut open pouch and remove Sleeve.
  • Remove the clear plastic insert.
  • Pull Sleeve onto knee, large ankle or elbow.
  • Medication is on the colored section of the Sleeve, so the colored section should be placed on the affected area.
  • Pull Sleeve over itself to make medicine touch directly on your skin.
  • Apply one Sleeve to affected area.
  • Repeat as necessary , but no more than 4 times a day.
  • Sleeve should fit snug, but not tight.
    • Children 12 years or younger: ask a doctor

Inactive Ingredients



Glycerin, Hydroxyethylcellulose, Isopropyl Alcohol, Polysorbate 80, Methylparaben, Propylparaben, Purified Water


Package Label



image of carton label - sleevelarge.carton

image of carton label - sleevelarge.carton


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