FDA Label for Lidocaine

View Indications, Usage & Precautions

Lidocaine Product Label

The following document was submitted to the FDA by the labeler of this product Premier Brands Of America 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 0.5%


​ ​Purpose



External analgesic


Uses



for the temporary relief of pain and itching associated with:

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

Warnings



For external use only.​ Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.


​Flammable:



Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F


​Do Not Use



in large quantities, particularly over raw surfaces or blistered areas.


When Using This Product



  • do not get into eyes
  • ask a doctor before using on children under 2 years of age

​Stop Use And Ask A Doctor If



  • conditions gets worse
  • symptoms last more than 7 days or clears up and occurs again in few days

​Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.


​Directions



  • shake can well
  • for adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily
  • for children under 2 years of age, ask a doctor
  • to apply to face spray in palm of hand and gently apply

​Other Information



store between 20° and 25°C (68°F and 77°)


​Inactive Ingredients



aloe barbadensis gel, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerine, methylparaben, propane, propylene glycol, propylparaben, tocopheryl acetate (vitamin E acetate), triethanolamine, simethicone, water


​ ​Questions?



call 1-866-964-0939


​Principal Display Panel



Premier

Burn Relief Spray

with Aloe

Cool and soothes

Relieves pain with lidocaine

For minor burns, cuts and scrapes

Cools, moisturizes and relieves itching

Net WT 4.5 OZ (127 g)


* Please review the disclaimer below.