83391-008 DailyMed Label

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% Menthol 1%

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

for the temporary pain relief

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

If you are allergic to the listed ingredients If you are pregnent or breast feeding If you are under 12 years of age On wounds, cuts, damaged/broken/irritated skin On eyes or mucous membranes With heating pads/devices or wrap with a bandage With other topical analgesics If the package arrives damaged or opened.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

■ Clean and dry the patch application area (no wound or hair), pull to separate the film, peel off one side of the film, apply the exposed patch to the skin, peel off the ■ Do not repeatedly use or repeatedly reapply the patch as far as possible ■ Cut first if if used on joints ■ Use in te affected area no more than 4 times daily ■ Wash hands with cool water after use

Other Label Information

STORAGE AND HANDLING SECTION

Avoid storing patches in direct sunlight Protect patches from excessive moisture. Store it at room temperature 20-25°c

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Hydroxyacetophenone Kaolin L(+)-Tartaric Acid Mineral oil Polysorbate 80 Polyacrylic Acid Polyvinylpyrrolidone K90 Propylene Glycol Sodium Polyacrylate Titanium Dioxide Water

Products

AUVON Lidocaine Menthol Pain Relief Patch
Lidocaine and Menthol

NDC Codes

Ingredients

Name	UNII	Kind
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
MINERAL OIL	T5L8T28FGP	IACT
POLYACRYLIC ACID (250000 MW)	9G2MAD7J6W	IACT
WATER	059QF0KO0R	IACT
KAOLIN	24H4NWX5CO	IACT
LEVOMENTHOL	BZ1R15MTK7	ACTIB
HYDROXYACETOPHENONE	G1L3HT4CMH	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
GLYCERIN	PDC6A3C0OX	IACT
DIHYDROXYALUMINUM AMINOACETATE	DO250MG0W6	IACT
LIDOCAINE	98PI200987	ACTIB
SODIUM POLYACRYLATE (2500000 MW)	05I15JNI2J	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
TARTARIC ACID	W4888I119H	IACT
POVIDONE K90	RDH86HJV5Z	IACT

Complete SPL Sections

SPL UNCLASSIFIED SECTION

AUVON LIDOCAINE MENTHOL Pain Relief Patch

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% Menthol 1%

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

for the temporary pain relief

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

If you are allergic to the listed ingredients If you are pregnent or breast feeding If you are under 12 years of age On wounds, cuts, damaged/broken/irritated skin On eyes or mucous membranes With heating pads/devices or wrap with a bandage With other topical analgesics If the package arrives damaged or opened.

OTC - WHEN USING SECTION

■ Read and follow all directions and warnings on this label ■ avoid contact with the eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

OTC - STOP USE SECTION

You are experiencing pain, swelling or blistering Redness is persent or irritation develops Symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 12years of age: do not use, consult a doctor.