AVADERM- lidocaine hcl, menthol cream

AvaDerm by

Drug Labeling and Warnings

AvaDerm by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Lidocaine HCL             4.00%                        Topical Analgesic

Menthol                      1.00%                        Topical Analgesic

PURPOSE

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVADERM 
lidocaine hcl, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-300-01	120 g in 1 PACKAGE; Type 0: Not a Combination Product	06/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/10/2015

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-300)