83391-008

83391-008
SPL v2
SPL
SPL Set ID 300cf469-5ca2-a40d-e063-6294a90a6801
Route
TOPICAL
Published
Effective Date 2025-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (100 mg) Lidocaine (400 mg)
Inactive Ingredients
Titanium Dioxide Propylene Glycol Mineral Oil Polyacrylic Acid (250000 Mw) Water Kaolin Hydroxyacetophenone Polysorbate 80 Glycerin Dihydroxyaluminum Aminoacetate Sodium Polyacrylate (2500000 Mw) Edetate Disodium Tartaric Acid Povidone K90

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-11

Description

AUVON LIDOCAINE MENTHOL Pain Relief Patch


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

for the temporary pain relief

Dosage and Administration

■ 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

Description

AUVON LIDOCAINE MENTHOL Pain Relief Patch

Section 42229-5

AUVON LIDOCAINE MENTHOL Pain Relief Patch

Section 44425-7

Avoid storing patches in direct sunlight

Protect patches from excessive moisture.

Store it at room temperature 20-25°c

Section 50565-1

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

Section 50566-9

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

Section 50567-7

■ 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.

Section 50570-1

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.

Section 51727-6

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

Section 51945-4

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine 4%

Menthol 1%


Structured Label Content

Indications and Usage (34067-9)

for the temporary pain relief

Dosage and Administration (34068-7)

■ 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

Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

AUVON LIDOCAINE MENTHOL Pain Relief Patch

Section 44425-7 (44425-7)

Avoid storing patches in direct sunlight

Protect patches from excessive moisture.

Store it at room temperature 20-25°c

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

■ 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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%

Menthol 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)