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AvaDerm by Pure Source, LLC

Medically reviewed on December 29, 2017

Dosage form: cream
Ingredients: LIDOCAINE HYDROCHLORIDE 4g in 100g, MENTHOL 1g in 100g
Labeler: Pure Source, LLC
NDC Code: 65121-300

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

AvaDerm

Active Ingredient:

Lidocaine HCL             4.00%                        Topical Analgesic

Menthol                      1.00%                        Topical Analgesic

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

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

AvaDerm

(Lidocaine - Menthol)

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:

  • 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.

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.

AVADERM 
lidocaine hcl, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA MONTANA FLOWER 
C13-14 ISOPARAFFIN 
CETOSTEARYL ALCOHOL 
CHONDROITIN SULFATE (BOVINE) 
EMU OIL 
ETHYLHEXYLGLYCERIN 
GLUCOSAMINE SULFATE 
GLYCERIN 
GLYCERYL STEARATE SE 
LAURETH-7 
DIMETHYL SULFONE 
PEG-100 STEARATE 
PHENOXYETHANOL 
POLYACRYLAMIDE (10000 MW) 
PROPYLENE GLYCOL 
STEARIC ACID 
TROLAMINE 
UREA 
Packaging
#Item CodePackage Description
1NDC:65121-300-01120 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/10/2015
Labeler - Pure Source, LLC (080354456)
Establishment
NameAddressID/FEIOperations
Pure Source, LLC080354456manufacture(65121-300)

 
Pure Source, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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