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  5. Label Information: Lidocaine 4 Percent

FDA Label for Lidocaine 4 Percent

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

Lidocaine 4 Percent Product Label

The following document was submitted to the FDA by the labeler of this product Sa3, Llc. 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 Analgesic


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



  • Avoid contact with the eyes
  • Do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use And Ask A Doctor



  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • If allergic reaction occurs or if 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 olderapply 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.


Principal Display Panel



Lidocaine HCl 4% cream

NDC 69420-6262-1 

Topical Analgesic Cream

4.2 OZ (120 g)

SA3, LLC

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TableDescription automatically generated - lidocaine 4 percent cream 01


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