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  5. Label Information: Cvs Health Lidocaine Pain-relieving

FDA Label for Cvs Health Lidocaine Pain-relieving

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. OTC - 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/CHILDREN 12 YEARS AND OLDER
    11. CHILDREN 12 YEARS OR YOUNGER:
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL – BOX LABEL
    15. PRINCIPAL DISPLAY PANEL – PATCH LABEL

Cvs Health Lidocaine 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 Ingredient



Lidocaine 4%


Purpose



Topical Analgesic


Use



For the temporary relief of pain.


Warnings



For external use only


Otc - Do Not Use



Do not use

  • more than one patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients in 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



  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • 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/Children 12 Years And Older



  • clean and dry affected area
  • remove film from patch and apply to the skin (see illustration)
  • apply to affected area, not more than 3 to 4 times daily
  • remove patch from the skin after, at most, 8-hour application

Children 12 Years Or Younger:



  • consult a doctor

Other Information



  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients



Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, Povidone, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.


Principal Display Panel – Box Label



CVS
Health

Compare to the active
ingredient in Salonpas®
4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine
Pain-Relieving
Patch

UP TO
8
HOURS

LIDOCAINE 4% GEL

Numbing muscle
& joint relief

For temporary relief of
minor aches & pains:

Principal Display Panel – Patch Label



CVS
Health

MAXIMUM STRENGTH

Lidocaine
Pain-Relieving
Patch

LIDOCAINE 4% GEL

Numbing muscle & joint relief

For temporary relief of
minor aches & pains:

* Please review the disclaimer below.