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 2021-01-20

Medication Information

Purpose

Topical Analgesic

Description

Menthol 4%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Simple backache
Arthritis
Strains
Bruises
Sprains

Section 42229-5

Adults and children 12 years of age and over:

apply to affected area using roller ball not more than 4 times daily
massage painful area until absorbed into skin
wash hands after each use with cold water

Section 50565-1

Keep out of reach of children.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
rash, itching, redness or excessive irritation of the skin develops
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

Section 50567-7

When using this product

Use only as directed
do not bandage tightly
avoid contact with eyes or mucous membranes

Section 50570-1

Do not use

if you are allergic to any ingredient in this product
on open wounds, damaged or irritated skin
with a heating pad or TENS device

Section 53414-9

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

Warnings

For external use only

Flammable:Keep away from fire or flame and heated surfaces

Active Ingredient

Menthol 4%

Other Information

store in a cool place away from direct sunlight
store with cap closed tightly

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 Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water

Principal Display Panel 89 Ml Tube Label

CVS

Health _®

Compare to the active

ingredient in Biofreeze ^®

Pain Relief Gel*

Pain

Relief

Gel

MENTHOL 4%

Fast-acting pain relief
Relieves muscle pain
Soothes aggravated nerves
Vanishing scent

3 FL OZ (89 mL)

Principal Display Panel 74 Ml Bottle Label

CVS

Health _®

Compare to the active

ingredient in Biofreeze ^®

Pain Relief Roll-On*

Pain Relief

Roll-On

MENTHOL 4%

Fast-acting pain relief
Relieves muscle pain
Soothes aggravated nerves
Vanishing scent

2.5 FL OZ (74 mL)

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Simple backache
Arthritis
Strains
Bruises
Sprains

Section 42229-5 (42229-5)

Adults and children 12 years of age and over:

apply to affected area using roller ball not more than 4 times daily
massage painful area until absorbed into skin
wash hands after each use with cold water

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 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens
rash, itching, redness or excessive irritation of the skin develops
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

Section 50567-7 (50567-7)

When using this product

Use only as directed
do not bandage tightly
avoid contact with eyes or mucous membranes

Section 50570-1 (50570-1)

Do not use

if you are allergic to any ingredient in this product
on open wounds, damaged or irritated skin
with a heating pad or TENS device

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 fire or flame and heated surfaces

Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)

store in a cool place away from direct sunlight
store with cap closed tightly

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 Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water

Principal Display Panel 89 Ml Tube Label (Principal Display Panel - 89 mL Tube Label)

CVS

Health _®

Compare to the active

ingredient in Biofreeze ^®

Pain Relief Gel*

Pain

Relief

Gel

MENTHOL 4%

Fast-acting pain relief
Relieves muscle pain
Soothes aggravated nerves
Vanishing scent

3 FL OZ (89 mL)

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

CVS

Health _®

Compare to the active

ingredient in Biofreeze ^®

Pain Relief Roll-On*

Pain Relief

Roll-On

MENTHOL 4%

Fast-acting pain relief
Relieves muscle pain
Soothes aggravated nerves
Vanishing scent

2.5 FL OZ (74 mL)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Bruises Sprains", "42229-5": "Adults and children 12 years of age and over: apply to affected area using roller ball not more than 4 times daily massage painful area until absorbed into skin wash hands after each use with cold water", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if condition worsens rash, itching, redness or excessive irritation of the skin develops symptoms persist for more than 7 days symptoms clear up and occur again within a few days", "50567-7": "When using this product Use only as directed do not bandage tightly avoid contact with eyes or mucous membranes", "50570-1": "Do not use if you are allergic to any ingredient in this product on open wounds, damaged or irritated skin with a heating pad or TENS device", "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 fire or flame and heated surfaces", "Active ingredient": "Menthol 4%", "Other information": "store in a cool place away from direct sunlight store with cap closed tightly", "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 Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water", "Principal Display Panel - 89 mL Tube Label": "CVS Health ® Compare to the active ingredient in Biofreeze ® Pain Relief Gel* Pain Relief Gel MENTHOL 4% Fast-acting pain relief Relieves muscle pain Soothes aggravated nerves Vanishing scent 3 FL OZ (89 mL)", "Principal Display Panel - 74 mL Bottle Label": "CVS Health ® Compare to the active ingredient in Biofreeze ® Pain Relief Roll-On* Pain Relief Roll-On MENTHOL 4% Fast-acting pain relief Relieves muscle pain Soothes aggravated nerves Vanishing scent 2.5 FL OZ (74 mL)"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information