Avaderm
FDA Label NDC 69677-020

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mas Management Group Inc. for the product Avaderm (NDC 69677-020). 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, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient:

Lidocaine HCL             4.00%                        Topical Analgesic

Menthol                      1.00%                        Topical Analgesic

Otc - Purpose

Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or skin irritations.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, consult physician.

Indications & Usage

AvaDerm

(Lidocaine - Menthol)

Dosage & Administration

Directions:

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.

Warnings

Warnings:

  • Avoid contact with eyes. 
  • If symptoms persist for more than seven days, discontinue use and consult physician.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • Do not bandage tightly.
  • If pregnant or breast feeding, contact physician prior to use.

Inactive Ingredient

Other Ingredients:

aqua (deionized water), arnica montana flower extract, C13-14 isoparaffin, cetearyl alcohol, chondroitin sulfate, emu oil, ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate, laureth-7, methylsulfonylmethane (MSM), PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, triethanolamine, urea.

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