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  5. Label Information: Cvs Health Roll-on Foot Pain Relief

FDA Label for Cvs Health Roll-on Foot Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER:
    11. CHILDREN UNDER 12 YEARS OF AGE:
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL – BOTTLE LABEL

Cvs Health Roll-on Foot Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Natural Essentials, 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 4%


Purpose



Topical Analgesic


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

Flammable: Keep away from fire or flame and heated surfaces


Do Not Use



  • if you are allergic to any ingredient in this product
  • on open wounds, damaged or irritated skin
  • with a heating pad or TENS device

When Using This Product



  • do not bandage tightly
  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes
  • rare cases of burns have been reported with products of this type
  • if severe burning sensation occurs, discontinue use immediately

Stop Use And Ask A Doctor If



  • condition worsens
  • rash, itching, redness or excessive irritation of the skin develops
  • symptoms persist for more than 7 days
  • symptoms 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.


Adults And Children 12 Years Of Age And Over:



  • apply to affected area using roller ball not more than 4 times daily
  • massage painful area until absorbed into skin
  • wash hands after each use with cold water

Children Under 12 Years Of Age:



  • consult a doctor

Other Information



  • store in a cool place away from direct sunlight
  • store with cap closed tightly

Inactive Ingredients



Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camelia Sinensis (Green Tea) Extract, Camphor, Carbomer 940, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.


Principal Display Panel – Bottle Label



CVS
Health®

Compare to the active
ingredient in Biofreeze®
Cold Therapy Roll-on*

Roll-On
Foot Pain
Relief

MENTHOL 4%

Temporarily Relieves
painful, achy feet

Soothes
aggravated
nerves

2.5 FL OZ (74 mL)


* Please review the disclaimer below.