83391-007

83391-007
SPL v4
SPL
SPL Set ID 2dacd6fe-7d69-bcf0-e063-6294a90a0351
Route
TOPICAL
Published
Effective Date 2025-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (0.04 mg)
Inactive Ingredients
Arnica Montana Flower Water Aloe Barbadensis Leaf Carbomer Ilex Paraguariensis Leaf Aminomethyl Propanol .alpha.-tocopherol Acetate Isopropyl Alcohol Water Fd&c Blue No. 1 Fd&c Yellow No. 5 Boswellia Serrata Oil Calendula Officinalis Flower Arctium Lappa Whole Isopropyl Myristate Camellia Sinensis Leaf Oil Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Glycerin Melissa Officinalis Leaf Oil Camphor (natural)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-08

Description

Auvon 4% Menthol Pain Relief Gel


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporary relief from minor aches and paons of sore muscles and joints

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 other side of the film, and press the patch firmly ■ Do not repeatedly use or repeatedly reapply the patch as far as possible

Use in te affected area no more than 4 times daily

Wash hands with cool water after use

Description

Auvon 4% Menthol Pain Relief Gel

Section 42229-5

Auvon 4% Menthol Pain Relief Gel

Section 44425-7

Store it in a dray place at a room temperature between 20-25°c and away from direct sunlight

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

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

■ Use only as directed

■ Read and follow all directions and warnings on this label

Section 50570-1

If you are under 12 years of age

If you are allergic to the listed ingredients

If you are pregnent or breast feeding

On wounds, cuts, damaged/broken/irritated skin

Section 51727-6

Arctium Lappa (Burdock) Extract

Arnica Montana Flower Extract

Aloe Barbadensis Leaf Juice

Aminomethyl Propanol

Boswellia Serrata Extract

Camellia Sinensis(Green Tea) Leaf Extract

Camphor

Carbomer

Calendula Officinalis Flower Extract

FD&C Blue NO.1

FD&C Yellow No.5

Isopropyl Alcohol

Isopropyl Myristate,

Glycerin

Llex Paraguariensis Leaf Extract

Melissa Officinalis Leaf Extract

Methyl Methacrylate Crosspolymer

Tocopheryl Acetate

Water

Section 51945-4

Section 55105-1

Topical Analgestic

Section 55106-9

Menthol 4%


Structured Label Content

Indications and Usage (34067-9)

Temporary relief from minor aches and paons of sore muscles and joints

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 other side of the film, and press the patch firmly ■ Do not repeatedly use or repeatedly reapply the patch as far as possible

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 4% Menthol Pain Relief Gel

Section 44425-7 (44425-7)

Store it in a dray place at a room temperature between 20-25°c and away from direct sunlight

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

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)

■ Use only as directed

■ Read and follow all directions and warnings on this label

Section 50570-1 (50570-1)

If you are under 12 years of age

If you are allergic to the listed ingredients

If you are pregnent or breast feeding

On wounds, cuts, damaged/broken/irritated skin

Section 51727-6 (51727-6)

Arctium Lappa (Burdock) Extract

Arnica Montana Flower Extract

Aloe Barbadensis Leaf Juice

Aminomethyl Propanol

Boswellia Serrata Extract

Camellia Sinensis(Green Tea) Leaf Extract

Camphor

Carbomer

Calendula Officinalis Flower Extract

FD&C Blue NO.1

FD&C Yellow No.5

Isopropyl Alcohol

Isopropyl Myristate,

Glycerin

Llex Paraguariensis Leaf Extract

Melissa Officinalis Leaf Extract

Methyl Methacrylate Crosspolymer

Tocopheryl Acetate

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgestic

Section 55106-9 (55106-9)

Menthol 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)