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  5. Label Information: Cvs Health Pain Relief

FDA Label for Cvs Health Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. OTHER
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL - 74 ML BOTTLE LABEL
    14. PRINCIPAL DISPLAY PANEL - 89 ML TUBE LABEL

Cvs Health 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


Otc - Do Not Use



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

Otc - When Using



When using this product

  • Use only as directed
  • do not bandage tightly
  • avoid contact with eyes or mucous membranes

Otc - Stop Use



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.


Other



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, 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 Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water


Principal Display Panel - 74 Ml Bottle Label



CVS
Health®

Compare to the active
ingredient in Biofreeze®
Pain Relief Roll-On*

Pain Relief
Roll-On

MENTHOL 4%

Principal Display Panel - 89 Ml Tube Label



CVS
Health®

Compare to the active
ingredient in Biofreeze®
Pain Relief Gel*

Pain
Relief
Gel

MENTHOL 4%

* Please review the disclaimer below.