83391-003 Menthol Pain Relief Roll-on

83391-003 Menthol Pain Relief Roll-on
SPL v2
SPL
SPL Set ID df239c4d-af6a-41ca-baed-d0788782ce9f
Route
TOPICAL
Published
Effective Date 2024-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Arctium Lappa Whole Arnica Montana Flower Indian Frankincense Calendula Officinalis Flower Green Tea Leaf Camphor (natural) Carbomer 940 Fd&c Blue No. 1 Fd&c Yellow No. 5 Ilex Paraguariensis Leaf Isopropyl Alcohol Isopropyl Myristate Melissa Officinalis Leaf Poly(methyl Methacrylate; 450000 Mw) Aminomethylpropanol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-21

Description

Drug Facts

Purpose

Topical Analgestic


Medication Information

Purpose

Topical Analgestic

Description

Drug Facts

Use

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

Section 51945-4

Storage

Store it in a dry place at room temperature between 20-25 C (68-77F) and away from direct sunlight.

Active I

Menthol 4%

Keep Out

If ingested, get medical help right away.

Warnings

Please read all directions and warnings as follows and use only as directed. For external use only

Directions
  • Rub a thin film over the affected area not more than 3 to 4 times daily
  • Wash hands after use
Do Not Use
  • If you are under 12 years of age, please consult a doctor
  • If you are allergic to the listed ingredients
  • If the package arrives damaged or opened.
  • If you are pregnent or breast feeding
  • At the same time as other topical analgesics
  • On eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, 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, Aminomethyl Propanol, Tocopheryl Acetate, Water

Menthol Auvon Pain Relief Roll On

Drug Facts

Discontinue Use and Consult A Doctor
  • if symptoms 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, or blistering

Structured Label Content

Use

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

Section 51945-4 (51945-4)

Purpose

Topical Analgestic

Storage

Store it in a dry place at room temperature between 20-25 C (68-77F) and away from direct sunlight.

Active I (Active i)

Menthol 4%

Keep Out (Keep out)

If ingested, get medical help right away.

Warnings

Please read all directions and warnings as follows and use only as directed. For external use only

Directions
  • Rub a thin film over the affected area not more than 3 to 4 times daily
  • Wash hands after use
Do Not Use (Do not use)
  • If you are under 12 years of age, please consult a doctor
  • If you are allergic to the listed ingredients
  • If the package arrives damaged or opened.
  • If you are pregnent or breast feeding
  • At the same time as other topical analgesics
  • On eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, 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, Aminomethyl Propanol, Tocopheryl Acetate, Water

Menthol Auvon Pain Relief Roll On (MENTHOL AUVON Pain Relief Roll-on)

Drug Facts

Discontinue Use and Consult A Doctor (Discontinue use and consult a doctor)
  • if symptoms 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, or blistering

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)