FDA Label for 0.5% Lidocaine Burn Relief

View Indications, Usage & Precautions

0.5% Lidocaine Burn Relief Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Center 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.

Drug Facts




Active Ingredient



Lidocaine HCl 0.5%


Purpose



External analgesic


Uses



for the temporary relief of pain and itching associated with • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations


Warnings



For external use only

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product avoid contact with the eyes

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


Otc - Keep Out Of Reach Of Children



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 of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor


Other Information



Store a room temperature • Protect from direct sunlight.


Inactive Ingredients



Aloe Barbadensis Leaf Juice, Carbomer, Disodium EDTA, Ethylhexylglycerin, FD&C Blue NO.1, FD&C Yellow NO.5, Glycerin, Menthol, Maltodextrin, Propanediol, Polysorbate 20, Phenoxyethanol, Sodium Hydroxide, SD Alcohol, Water.


Packaging




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