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Drug Facts
Medi-first Burn With Lidocaine Cream
FDA Label NDC 47682-270
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 Medi-first Burn With Lidocaine (NDC 47682-270). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients
Benzalkonium chloride 0.13%
Lidocaine HCl 0.5%
Otc - Purpose
Purposes
First aid antiseptic
External analgesic
Indications & Usage
Uses
first aid to help prevent infection and for the temporary relief of pain and itching associated with
- minor cuts
- scrapes
- burns
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
- in the eyes or apply over large areas of the body
- longer than 1 week unless directed by a doctor
- in large quantities, particularly over raw surfaces or blistered areas
Otc - Ask Doctor
Ask a doctor before use if you have
deep or puncture wounds, animal bites or serious burns
Otc - When Using
When using this product avoid contact with the eyes
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days
- condition clears up and occurs 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 immediately.
Dosage & Administration
Directions
- adults and children 2 years of age and older:
- clean the affected area
- apply a small amount of this product on the area 1 to 3 times daily
- may be covered with a sterile bandage
- children under 2 years of age: consult a doctor
Other Safety Information
Other information
- store at room temperature
- tamper evident. Do not use if packet is opened or torn
- you may report a serious adverse reaction to this product to 800-634-7680
Inactive Ingredient
Inactive ingredients
aloe barbadensis leaf juice, cetyl alcohol, diazolidinyl urea, disodiun EDTA,, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG 100, propylene glycol, propylparaben, stearic acid, triethanolamine, water
Otc - Questions
Questions or comments? 1-800-634-7680
Package Label.Principal Display Panel
Medi-First®
Burn Cream with Lidocaine
Benzalkonium Chloride 0.13% / First Aid Antiseptic
Lidocaine HCl 0.5% / External Analgesic
Product # 20669
10 Units Net Wt 0.9 g (1/32 oz)
Medi-First® Plus
Burn Cream with Lidocaine
Benzalkonium Chloride 0.13% / First Aid Antiseptic
Lidocaine HCl 0.5% / External Analgesic
25 Units of 0.9 g Packets
Item #93973
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