Active Ingredient
Lidocaine Hydrochloride USP 2%
Burn Ease Gel
FDA Label NDC 58228-2010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prostat First Aid Llc for the product Burn Ease (NDC 58228-2010). 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, use(s), 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
Analgesic
Use(S)
For the temporary relief of pain associated with • Minor burns • Sunburn
Warnings
For External Use Only
Do Not Use
• On wounds or damaged skin
• In large quantities, particularly over raw surfaces or blistered areas
When Using This Product
• Avoid contact with the eyes
• Do not bandage tightly
Stop Use And Ask A Doctor If
• Condition worsens
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 of age: Consult a doctor
Other Information
• Store at controlled room temperature 20°-25°C (68°-77°F)
• Tamper Evident. Do not use if seal is damaged.
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosscopolymer, Carbomer, Glycerin, Imidazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Oil, Trolamine
Questions?
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Label
Ps-8610_bx_master (Ps 8610 Bx Master R231103 3)
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