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  5. Label Information: Lidocaine 4%

FDA Label for Lidocaine 4%

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. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Lidocaine 4% 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 HCl 4% w/w


Purpose



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

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: ask a doctor


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



Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.


Package/Label Principal Display Panel



LIDOCAINE 4%
Topical Anesthetic Cream

120 grams

NDC: 50488-6262-1

Manufactured for: Alexso Inc.
2317 Cotner Avenue Los Angeles, CA 90064
Tel: 888.495.6078 Web: www.alexso.com

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Label


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