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  5. Label Information: Cvs Health Pain Relieving

FDA Label for Cvs Health Pain Relieving

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL - 60 PATCH BOX LABEL
    14. PRINCIPAL DISPLAY PANEL - 20 PATCH POUCH LABEL

Cvs Health Pain Relieving 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 Ingredients



Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%


Purpose



Topical analgesic

Topical analgesic

Topical analgesic


Uses



For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings



For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.


Do Not Use



  • on wounds or damaged skin with a heating pad
  • if you are allergic to any ingredients of this product

When Using This Product



  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop Use And Ask A Doctor If



  • rash, itching or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

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.


Directions



  • Adults and children 12 years of age and over: clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • remove patch from the skin after at most 8 hour application

    • Children under 12 years of age: consult a doctor


Other Information



  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive Ingredients



hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer


Principal Display Panel - 60 Patch Box Label



CVS
Health®

Compare to the active ingredients in
Salonpas® Pain Relieving Patch*

EXTRA STRENGTH

Pain-Relieving
Patch

CAMPHOR 3.1%

MENTHOL 6.0%

METHYL SALICYLATE 10.0%

Topical analgesic/Pain reliever

APPLY FOR
8
HOURS

For temporary relief of minor
aches & pains:

  • Stiff neck
  • Sore shoulders
  • Backache
  • Joint pain

    • 60 PATCHES†

    †Contains 3 pouches with 20 patches in each

    2.83" X 1.81" (7.2 CM X 4.6 CM)

    Figure - cvs0z 0000 01

    Figure - cvs0z 0000 01


Principal Display Panel - 20 Patch Pouch Label



CVS
Health®

EXTRA STRENGTH

Pain-Relieving
Patches

CAMPHOR 3.1%

MENTHOL 6.0%

METHYL SALICYLATE 10.0%

Topical analgesic/Pain reliever

APPLY FOR
8
HOURS

For temporary relief of minor
aches & pains:

* Please review the disclaimer below.