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Drug Facts
Burn Spray
FDA Label NDC 73598-0671
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jhk Inc for the product Burn (NDC 73598-0671). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine HCl 2%
Purpose
Topical pain reliever
Uses
For the temporary relief of pain associated with minor burns.
Warnings
For external use only.
Do Not Use
- in large quantities, particularly over raw surfaces or blistered areas.
Otc - When Using
When using this product avoid contact with the eyes.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or persist for more then 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 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: consult a doctor
Other Information
- store at room temperature
Inactive Ingredients
Aloe vera, germaben II, propylene glycol, purified water
Questions?
1-866-651-3660
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Manufactured for American Safety & First Aid Osceola, IN 46561
V1_11-7-19
Principal Display Panel – Bottle Label
0671
NDC 73598-0671-1
Burn Spray
Topical Pain Relief
For Temporary Pain
Relief of Minor Burns.
American Safety
& First Aid
2 fl. Oz. (59.1 ml)
Principal Display Panel – Bottle Label (Bur03 0000 01)
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