FDA Label for Lidocaine 4 Percent Plus

View Indications, Usage & Precautions

Lidocaine 4 Percent Plus 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, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, Magnesium Sulfate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.


Principal Display Panel



NDC 50488-6263-1

Lidocaine 4% PLUS Cream

120 grams

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

Label


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