FDA Label for Burn

View Indications, Usage & Precautions

Burn Product Label

The following document was submitted to the FDA by the labeler of this product Acme United Corp. 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.

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Drug Facts


Active Ingredient



Lidocaine HCl 2.0%


Purpose



Topical pain relief


Uses



temporary pain relief associated with minor burns


Warnings



For external use only


Do Not Use



  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Otc - Stop Use



Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away


Directions



  • adults and children 2 years of age and older: spray an even layer of burn spray over affected area not more than 3-4 times daily
  • for children under 2 years of age: consult a physician

Inactive Ingredients



aloe vera, germaben II, propylene glycol, purified water


Questions?



call 203-857-5361


Principal Display Panel - Bottle Label



13-040

BURNS

FIRST AID ONLY®

Burn Spray

Pain relieving spray
for use on minor burns

4 fl oz (118.3ml)


* Please review the disclaimer below.