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  5. Label Information: Avaderm

FDA Label for Avaderm

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. DOSAGE & ADMINISTRATION
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Avaderm Product Label

The following document was submitted to the FDA by the labeler of this product Mas Management Group Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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