Otc - Active Ingredient
Active ingredient
Lidocaine HCl 2.0%
Green Guard Burn Spray
FDA Label NDC 47682-330
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Green Guard Burn (NDC 47682-330). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical pain relief
Indications & Usage
Uses
Temporary pain relief associated with minor burns
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
- in large quantities, particularly over raw or blisterd 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 a Poison Control Center right away.
Dosage & Administration
Directions
- spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
- not to be used on children under 12 years of age
Inactive Ingredient
Inactive ingredients
glycerin, hdroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water
Otc - Questions
Questions or comments? 1-800-869-6970
Package Label.Principal Display Panel
Burn Spray
Lidocaine HCl 2.0%
TopicalPain Relief
Relieves pain of minor burns
Store at 68°-77°F (20°-25°C)
Green Guard®
2 fl oz (59.1 mL)
* Please review the disclaimer below.
