84992-002 Avcoo Menthol And Methyl Salicylate Pain Relief Roll-on

84992-002 Avcoo Menthol And Methyl Salicylate Pain Relief Roll-on
SPL v1
SPL
SPL Set ID 420d8cdc-f47f-4d33-bf25-9033ff266c49
Route
TOPICAL
Published
Effective Date 2025-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Salicylic Acid (20 g)
Inactive Ingredients
Water Aloe Vera Leaf Capsaicin Aminomethylpropanol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s At 0.5%) Arnica Montana Flower Water Cetearyl Alcohol Ethylhexylglycerin Maltodextrin Phenoxyethanol Propylene Glycol Potassium Cetyl Phosphate .alpha.-tocopherol Acetate

Identifiers & Packaging

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

Description

Active ingredient Menthol 10% Methyl Salicylate: 20%


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
  • For sensitive skins, use with caution
  • So not squeeze the bottle during application
Indications and Usage

Uses

Temporary relief from 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 10% Methyl Salicylate: 20%

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 you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering
  • if condition worsens, or if syptoms persist for more than 7 days or clear up and occur again within a few days.
Section 50570-1

Do not use

  • if you are allergic to the listed ingredients
  • with a heating pad
  • on mucous membrances, cuts, broken, swollen, or irritated skin
Section 51727-6

Inactive ingredients

Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water

Section 51945-4

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active ingredient

Menthol 10%

Methyl Salicylate: 20%


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary relief from 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
  • For sensitive skins, use with caution
  • So not squeeze the bottle during application
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 you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering
  • if condition worsens, or if syptoms persist for more than 7 days or clear up and occur again within a few days.
Section 50570-1 (50570-1)

Do not use

  • if you are allergic to the listed ingredients
  • with a heating pad
  • on mucous membrances, cuts, broken, swollen, or irritated skin
Section 51727-6 (51727-6)

Inactive ingredients

Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 10%

Methyl Salicylate: 20%


Advanced Ingredient Data


Raw Label Data

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