AVADERM- lidocaine hcl, menthol cream 
MAS Management Group Inc.

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.

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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:

Warnings:

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.

image description

AVADERM 
lidocaine hcl, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69677-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
EMU OIL (UNII: 344821WD61)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
LAURETH-7 (UNII: Z95S6G8201)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
UREA (UNII: 8W8T17847W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69677-020-01120 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/2015
Labeler - MAS Management Group Inc. (079363782)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, Inc.969241041manufacture(69677-020)

Revised: 7/2015
Document Id: 4809d1a1-f59d-4f8e-a3f1-80e07af046c5
Set id: ef798c3e-a2b4-460a-a43d-0c59b2962cf1
Version: 1
Effective Time: 20150702
 
MAS Management Group Inc.