Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ede15818-5d17-477d-a8be-7b36bb0770a6
Route
TOPICAL
Published
Effective Date 2024-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (36 mg)
Inactive Ingredients
Aloe Vera Leaf Arctium Lappa Root Arnica Montana Flower Indian Frankincense Calendula Officinalis Flower Green Tea Leaf Camphor (synthetic) Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Fd&c Blue No. 1 Fd&c Yellow No. 5 Glycerin Isopropyl Alcohol Isopropyl Myristate Ilex Paraguariensis Leaf Silicon Dioxide .alpha.-tocopherol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

Menthol 4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 4%

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1

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

Section 53414-9

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

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

Directions
  • adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water
Active Ingredient

Menthol 4%

Other Information
  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight
Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguanensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.

When Using This Product
  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device
Stop Use and Ask A Doctor If
  • you experience pain, swelling or blistering oi the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age
Principal Display Panel – 89 Ml Tube Label

Walgreens

Compare to the active

ingredient in Biofreeze® Gel
††

WALGREENS PHARMACIST RECOMMENDED

Cold

Therapy

Pain Relief

Gel

MENTHOL 4% / TOPICAL ANALGESIC

Cooling Pain Relief

  • For the temporary relief of arthritis,

    back pain, sore muscles & joints
  • Soothing menthol
  • Paraben free

3 FL OZ (89 ml)

Principal Display Panel – 74 Ml Bottle Label

Walgreens

Compare to the active ingredient

in Biofreeze
® Roll-On ††

WALGREENS PHARMACIST RECOMMENDED

Cold Therapy

Pain Relief

MENTHOL 4% / TOPICAL ANALGESIC

Roll On

Cooling Pain Relief

  • For the temporary relief of arthritis,

    back pain, sore muscles & joints
  • Soothing menthol
  • Paraben free

2.5 FL OZ (74 ml)


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Purpose

Topical Analgesic

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

Directions
  • adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water
Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguanensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience pain, swelling or blistering oi the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age
Principal Display Panel – 89 Ml Tube Label (Principal Display Panel – 89 mL Tube Label)

Walgreens

Compare to the active

ingredient in Biofreeze® Gel
††

WALGREENS PHARMACIST RECOMMENDED

Cold

Therapy

Pain Relief

Gel

MENTHOL 4% / TOPICAL ANALGESIC

Cooling Pain Relief

  • For the temporary relief of arthritis,

    back pain, sore muscles & joints
  • Soothing menthol
  • Paraben free

3 FL OZ (89 ml)

Principal Display Panel – 74 Ml Bottle Label (Principal Display Panel – 74 mL Bottle Label)

Walgreens

Compare to the active ingredient

in Biofreeze
® Roll-On ††

WALGREENS PHARMACIST RECOMMENDED

Cold Therapy

Pain Relief

MENTHOL 4% / TOPICAL ANALGESIC

Roll On

Cooling Pain Relief

  • For the temporary relief of arthritis,

    back pain, sore muscles & joints
  • Soothing menthol
  • Paraben free

2.5 FL OZ (74 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)