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  5. Label Information: Cvs Health Cold And Hot Roll-on Menthol

FDA Label for Cvs Health Cold And Hot Roll-on Menthol

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. FLAMMABLE
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS: ADULTS AND CHILDREN OVER 12 YEARS:
    11. CHILDREN 12 YEARS OR YOUNGER
    12. OTHER INFORMATION:
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL - COLD & HOT ROLL-ON MENTHOL 16% BOX LABEL
    15. PRINCIPAL DISPLAY PANEL - COLD & HOT ROLL-ON MENTHOL 16% CONTAINER LABEL

Cvs Health Cold And Hot Roll-on Menthol 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 16%


Purpose:



Topical analgesic


Uses:



  • temporarily relieves minor pain associated with:
    • arhtritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps

Warnings:



For external use only.


When Using This Product



  • use only as directed. Read and follow all directions and warnings on this label.
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) or medicated patch to the area of use
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight
  • avoid applying into skin folds.

Stop Use And Ask A Doctor If



  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Flammable



  • Keep away from fire or flame.

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:



  • apply a thin layer to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children 12 Years Or Younger



  • ask a doctor

Other Information:



Store in a cool dry area. Close cap tightly after use.


Inactive Ingredients



Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Capsaicin, Deionized Water, Glycerin, Isopropyl Myristate, Propylene Glycol, SDA 40-2 Alcohol.


Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label



CVS
Health™

Compare to the active
ingredient in Maximum
Strength IcyHot®
Pain Relieving Liquid

MAXIMUM STRENGTH

Cold & Hot
Roll-On

MENTHOL 16%

Pain-relieving liquid

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label



CVS
Health™

MAXIMUM STRENGTH

Cold & Hot
Roll-On

MENTHOL 16%

Pain-relieving liquid

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