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 Hart Health. 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.

Otc - Active Ingredient



Active Ingredients:

Lidocaine HCL 2%


Otc - Purpose



Purpose:

Topical Anesthetic


Indications & Usage



Uses:

Temporary pain relief of minor burns


Warnings



Warnings

For external use only

See a doctor immediately or serious burns


Otc - Do Not Use



Do not use

  • in or near the eyes
  • over large portions of the body
  • in large quantities particularly over raw surfaces or blistered areas
  • on serious burns
  • longer than 7 days unless directed by a doctor

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens
  • condition lasts for more than 7 days
  • symptoms 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. 1-800-222-1222


Dosage & Administration



Directions:

Adults and children 12 years of age and over:

  • clean the affected area
  • apply to the affected area not more than 3 to 4 times dailys
  • may be covered with a sterile bandage when dry
  • Children under 12 years of age: ask a doctor


Inactive Ingredient



Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water 


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