AVCOO MENTHOL PAIN RELIEF PATCH- menthol patch

AVCOO Menthol Pain Relief Patch by

Drug Labeling and Warnings

AVCOO Menthol Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by ADP Health Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

AVCOO Menthol Pain Relief Patch

ACTIVE INGREDIENT

Menthol 5%

PURPOSE

Topical anesthetic

INDICATIONS & USAGE

INDICATIONS & USAGE

INDICATIONS & USAGE

for the temporary pain relief

WARNINGS

For external use only

DO NOT USE

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.

WHEN USING

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.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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

STORAGE AND HANDLING

Avoid storing patches in direct sunlight

Protect patches from excessive moisture

P lease store it at room temperature.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVCOO MENTHOL PAIN RELIEF PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84992-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	500 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
KAOLIN (UNII: 24H4NWX5CO)
ALOE BARBADENSIS LEAF POWDER (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
MINERAL OIL (UNII: T5L8T28FGP)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
PVP (UNII: FZ989GH94E)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
FRANKINCENSE (UNII: R9XLF1R1WM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84992-004-01	1 in 1 BAG; Type 0: Not a Combination Product	03/13/2025
2	NDC: 84992-004-02	10 in 1 BOX; Type 0: Not a Combination Product	03/13/2025
3	NDC: 84992-004-03	18 in 1 BOX; Type 0: Not a Combination Product	03/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/13/2025

Labeler - ADP Health Limited (101747972)