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  5. Label Information: Lidocaine

FDA Label for Lidocaine

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. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Lidocaine Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. 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 anesthetic


Uses



For temporary relief of pain


Warnings



For external use only


Do Not Use



  • •more than 1 patch at a time
  • •on wounds or damaged skin
  • •with a heating pad
  • •if you have ever had an allergic reaction to this product or any of its ingredients

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

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 (1-800-222-1222).


Directions



Adults and children 12 years of age and over:

  • •clean and dry affected area
  • •remove film from patch and apply to the skin (see illustration)
  • •apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • •remove patch from the skin after at most 8 hours of application

    • Children under 12 years of age: consult a doctor


Other Information



  • •avoid storing product in direct sunlight
  • •protect product from excessive moisture
  • •store at 20-25°C (68-77°F)

Inactive Ingredients



carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, tartaric acid, urea


Questions Or Comments?



1-800-632-6900


Package/Label Principal Display Panel



COMPARE TO the active ingredient of SALONPAS® LIDOCAINE PATCH See back panel.

Maximum Strength

Lidocaine Patch

4% Lidocaine/Topical Anesthetic

For Back, Neck, Knees, Shoulders & Elbows

Up to 8 Hours of Relief

For Temporary Relief of Pain

Desensitize Aggravated Nerves

Numbing Relief

Unscented

6 PATCHES

3 15/16 IN X 5 ½ IN (10cm x 14cm)


* Please review the disclaimer below.