FDA Label for Burn Treatment

View Indications, Usage & Precautions

Burn Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Cmc Group 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 Ingredients



Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%


Purpose



First aid antiseptic

Pain relieving cream


Uses



  • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes

Warnings



For external use only.


Do Not Use



• in the eyes  • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor


Ask A Doctor Before Use If You Have



• deep or puncture wounds • animal bites • serious burns.


Stop Use And Ask A Doctor If



• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days


Keep Out Of Reah Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Clean the affected area
  • Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
  • Children under 2 years of age: consult a doctor
  • May be covered with a sterile bandage

Other Information



Store at room temperature


Inactive Ingredients



glycerin monostearate, glycerol, purified water


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