84992-003 Avcoo 4% Menthol Pain Relief

84992-003 Avcoo 4% Menthol Pain Relief
SPL v1
SPL
SPL Set ID 700ce2cf-749e-40be-91c3-850d9b2168ca
Route
TOPICAL
Published
Effective Date 2025-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Water Aloe Vera Leaf Glycerin Aminomethylpropanol Arctium Lappa Whole Arnica Montana Flower Water Boswellia Serrata Whole Calendula Officinalis Flower Camellia Sinensis Leaf Camphor, (-)- Carbomer 934 Fd&c Blue No. 1 Fd&c Yellow No. 5 Ilex Paraguariensis Leaf Isopropyl Alcohol Isopropyl Myristate Melissa Officinalis Leaf .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-18
Description

Active ingredient Menthol 4%

Medication Information

Warnings and Precautions

Warnings

  • Please read all directions and warnings as follows and use only as directed. For external use only.
  • Flammable:Keep away from excessive heat and open flame
  • Do not heat or microwave
  • Do not add to hot water or any container with heated water, as it may cause splattering and resultin burns
  • Do not bandage tightly
  • Avoid contact with eyes
  • Do not apply to wounds or damaged skin
Indications and Usage

Uses

Temporarily relieves minor aches and pains of sore muscles and joints associatedly with:

simple backaches, arthritis, strains, bruises, and sprain

Dosage and Administration

Directions 

  • Rub a thin film over the affected area no more than 3-4 times daily
  • Wash hands after use with cold water
  • Children under 12 years of age: do not use, consult a doctor
Description

Active ingredient Menthol 4%

Section 42228-7

If pregnant or breast-feeding,ask a healthcare professional before use

Section 44425-7

Other Information

  • store in a dry place at room temperature between 20-25C (77-86F) and away from direct sunlight
Section 50565-1

Keep out of reach of  children or pets. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop Use and Ask a Doctor

if condition worsens, or if syptoms persist for more than 7 days or clear up and occur again within a few days.

if you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering

Section 50570-1

Do not use

  • if you are allergic to the listed ingredients
  • if the package arrives damagedor opened
  • at the same time as other topical analgesics
  • on mucous membrances, cuts, broken, swollen, or irritated skin
Section 51727-6

Inactive ingredients

Arctium Lappa Extract, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol,  Boswellia Serrata Extrac, Calendula Officinalis Flower Extract,  Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue No.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, IsopropyI Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water

Section 51945-4

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active ingredient

Menthol 4%

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves minor aches and pains of sore muscles and joints associatedly with:

simple backaches, arthritis, strains, bruises, and sprain

Dosage and Administration (34068-7)

Directions 

  • Rub a thin film over the affected area no more than 3-4 times daily
  • Wash hands after use with cold water
  • Children under 12 years of age: do not use, consult a doctor
Warnings and Precautions (34071-1)

Warnings

  • Please read all directions and warnings as follows and use only as directed. For external use only.
  • Flammable:Keep away from excessive heat and open flame
  • Do not heat or microwave
  • Do not add to hot water or any container with heated water, as it may cause splattering and resultin burns
  • Do not bandage tightly
  • Avoid contact with eyes
  • Do not apply to wounds or damaged skin
Section 42228-7 (42228-7)

If pregnant or breast-feeding,ask a healthcare professional before use

Section 44425-7 (44425-7)

Other Information

  • store in a dry place at room temperature between 20-25C (77-86F) and away from direct sunlight
Section 50565-1 (50565-1)

Keep out of reach of  children or pets. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop Use and Ask a Doctor

if condition worsens, or if syptoms persist for more than 7 days or clear up and occur again within a few days.

if you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering

Section 50570-1 (50570-1)

Do not use

  • if you are allergic to the listed ingredients
  • if the package arrives damagedor opened
  • at the same time as other topical analgesics
  • on mucous membrances, cuts, broken, swollen, or irritated skin
Section 51727-6 (51727-6)

Inactive ingredients

Arctium Lappa Extract, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol,  Boswellia Serrata Extrac, Calendula Officinalis Flower Extract,  Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue No.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, IsopropyI Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 4%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:35.253866 · Updated: 2026-03-14T23:07:36.685051