Otc - Active Ingredient
Active Ingredient
Lidocaine ............. 0.5%
Myderm Aloe And Lidocaine Gel
FDA Label NDC 53329-037
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries for the product Myderm Aloe And Lidocaine (NDC 53329-037). 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 - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Lidocaine 0.5% ............. Pain Reliever
Indications & Usage
Temporary relief of pain and itching due to
- sunburn - minor burn - insect bites - minor cuts - scraps
Warnings
Warnings
For external use only
When using this product keep out of eyes
Rinse with warter to remove
Otc - Stop Use
Sop use and ask a doctor
system persist for more than 7 days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.
Dosage & Administration
Direction
Adults and children 2 years and older: aooly to affected area not more that 3-4 times a day
Children under 2 years of age: consult a physician.
Inactive Ingredient
Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.
Package Label.Principal Display Panel
Pain Reliever Aloe Gel Lidocain Hci 0.5% (203612 022519)
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