84992-004

84992-004
SPL v1
SPL
SPL Set ID 3036804b-16c3-0c88-e063-6394a90a3084
Route
TOPICAL
Published
Effective Date 2025-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (500 mg)
Inactive Ingredients
Propylene Glycol Kaolin Aloe Barbadensis Leaf Powder Arnica Montana Flower Mineral Oil Carboxymethylcellulose Sodium (0.7 Carboxymethyl Substitution Per Saccharide; 100-200 Mpa.s At 1%) Hydroxyacetophenone Water Dihydroxyaluminum Aminoacetate Pvp Polyacrylic Acid (250000 Mw) Petrolatum Polysorbate 80 Glycerin Edetate Disodium Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Tartaric Acid Frankincense

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-13

Description

AVCOO 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

AVCOO Menthol Pain Relief Patch

Section 42229-5

AVCOO Menthol Pain Relief Patch

Section 44425-7

Avoid storing patches in direct sunlight

Protect patches from excessive moisture

P lease store it at room temperature.

Section 50565-1

If ingested, 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

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

Aloe Barbadensis Leaf Extract

Arnica Montana Flower Extract

Boswellia Carterii Resin Extract

Camellia Sinensis Leaf Extract

Carboxymethylcellulose Sodium

Dihydroxyaluminum Aminoacetate

Edetate Disodium

Glycerin

Hydroxyacetophenone

Kaolin

L-Tartaric Acid

Mineral Oil

Petrolatum

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

PVP

Sodium Polyacrylate

Titanium Dioxide

Water

Section 51945-4

Section 55105-1

Topical anesthetic

Section 55106-9

Menthol 5%


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)

AVCOO Menthol Pain Relief Patch

Section 44425-7 (44425-7)

Avoid storing patches in direct sunlight

Protect patches from excessive moisture

P lease store it at room temperature.

Section 50565-1 (50565-1)

If ingested, 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

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)

Aloe Barbadensis Leaf Extract

Arnica Montana Flower Extract

Boswellia Carterii Resin Extract

Camellia Sinensis Leaf Extract

Carboxymethylcellulose Sodium

Dihydroxyaluminum Aminoacetate

Edetate Disodium

Glycerin

Hydroxyacetophenone

Kaolin

L-Tartaric Acid

Mineral Oil

Petrolatum

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

PVP

Sodium Polyacrylate

Titanium Dioxide

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Menthol 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)