Active Ingredient
Lidocaine HCL 2%
American Safety First Aid Spray
FDA Label NDC 71927-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Orazen Inc for the product American Safety First Aid (NDC 71927-012). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
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
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist more than 7 days
- condition clears up and occurs again within a few days
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
- you may report a serious adverse reaction to this product to 1-866-651-3660
Inactive Ingredients
glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water
Questions?
1-866-651-3660
Mon-Fri 8:00am-5:00pm EST
Package Label - Principal Display Panel
Image Of Bottle Label (2)
* Please review the disclaimer below.
