AVADERM- lidocaine hcl, menthol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

MAS Management Group Inc.

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

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:_
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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 6 77-0 20
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -
UNII:9 8 PI20 0 9 8 7)
LIDOCAINE HYDROCHLORIDE
ANHYDROUS
4 g
in 10 0 g
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
1 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)
C13 -14 ISO PARAFFIN (UNII: E