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  5. Label Information: Lidocaine 4 Percent And Menthol 1 Percent Roll-on

FDA Label for Lidocaine 4 Percent And Menthol 1 Percent Roll-on

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. KEEP OUT OF REACH OF CHILDREN.​
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PRINCIPAL DISPLAY PANEL

Lidocaine 4 Percent And Menthol 1 Percent Roll-on Product Label

The following document was submitted to the FDA by the labeler of this product Alexso, 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%
Menthol 1%


Purpose



Topical anesthetic
Topical anesthetic


Uses



Temporarily relieves pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations

Warnings



​For external use only.


When Using This Product



  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not apply to wounds or damaged skin
  • do not bandage

Stop Use And Ask A Doctor If



  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep Out Of Reach Of Children.​



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



 adults and children 2 years and older apply externally to the affected area up to 3 to 4  times a day
 children under 2 years do not use except under the advice and supervision of a physician

Other Information



  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Inactive Ingredients



Glycerin, Borneol, Arnica Montana Flower Extract, Polyethylene Glycol (PEG), Frankincense Oil, Boswellia Extract, Methylsulfonylmethane (MSM), Chondroitin Sulfate, Glucosamine Sulfate, Water


Principal Display Panel



Lidocaine 4% and Menthol 1% Roll-On

NDC 50488-6541-1

50 mL

Manufactured for:
Alexso, Inc.
Los Angeles, CA 90064

Lidocaine 4% and Menthol 1% Roll-OnNDC 50488-6541-150 mLManufactured for: Alexso, Inc. Los Angeles, CA 90064 - lidocaine and menthol roll on 01

Lidocaine 4% and Menthol 1% Roll-OnNDC 50488-6541-150 mLManufactured for: Alexso, Inc. Los Angeles, CA 90064 - lidocaine and menthol roll on 01


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