FDA Label for 4 Lidocaine Topical Anesthetic

View Indications, Usage & Precautions

4 Lidocaine Topical Anesthetic Product Label

The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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



Active ingredient


Purpose



Topical Analgesic


Uses



temporarily relieves pain and itching due to:

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

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
  • Do not apply over large areas of the body.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.

Other Information



  • Store at USP controlled room temperature 20° to 25°C (68° to 77°F)

Inactive Ingredients



aloe barbadensis leaf extract, benzyl alcohol, carbomer 940, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid, trolamine


Questions & Comments?



1-800-645-2158


Package Labeling:




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