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  5. Label Information: Salonpas Lidocaine Pain Relieving

FDA Label for Salonpas Lidocaine Pain Relieving

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. PRINCIPAL DISPLAY PANEL

Salonpas Lidocaine Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Hisamitsu Pharmaceutical Co., 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 anesthetic


Uses



For temporary relief of pain


Warnings



For external use only


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 igredients 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



  • localized skin reactions occur, such as rash, itching, redness, irritaion, 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.


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 to affected are 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



aluminum silicate, dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, methylparaben, oleic acid, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water


Questions Or Comments?



Toll free 1-800-826-8861   www.salonpas.us


Principal Display Panel



OTC topical analgesics
in patch format*
WORLD'S BRAND NO.1

Hisamitsu

NDC#46581-830-06

Desensitize aggravated nerves
for temporary relief of pain

  • Back
  • Neck
  • Shoulders
  • Knees and Elbows

    • Salonpas LIDOCASINE 4% Pain Relieving Gel-Patch
    APPLY FOR 8 HOURS
    MAXIMUM STRENGTH*1

    • Numbing Relief
    • Unscented

      • 6 PATCHES

      3 15/16" X 5 1/2" (10cm X 14cm)

      MADE IN JAPAN


* Please review the disclaimer below.