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) Glycerin Isopropyl Alcohol Isopropyl Myristate Ilex Paraguariensis Leaf Silicon Dioxide .alpha.-tocopherol Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-12-04

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 Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Ilex Paraguariensis 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 of 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

WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredient

in Biofreeze ^® Overnight Gel ^††

OVERNIGHT

Cold

Therapy

Pain Relief

Gel

MENTHOL 4%/TOPICAL ANALGESIC

For arthritis, back pain,

sore muscles & joints
Soothing menthol
Paraben free

Lavender

scent

3 FL OZ (89 mL)

Principal Display Panel – 74 Ml Bottle Label

Walgreens

WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredient

in Biofreeze ^® Roll-On ^††

OVERNIGHT

Cold Therapy

Pain Relief

MENTHOL 4%/TOPICAL ANALGESIC

Roll On

No Mess

For arthritis, back pain,

sore muscles & joints
Soothing menthol
Paraben free

Lavender

scent

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 Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Ilex Paraguariensis 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 of 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

WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredient

in Biofreeze ^® Overnight Gel ^††

OVERNIGHT

Cold

Therapy

Pain Relief

Gel

MENTHOL 4%/TOPICAL ANALGESIC

For arthritis, back pain,

sore muscles & joints
Soothing menthol
Paraben free

Lavender

scent

3 FL OZ (89 mL)

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

Walgreens

WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredient

in Biofreeze ^® Roll-On ^††

OVERNIGHT

Cold Therapy

Pain Relief

MENTHOL 4%/TOPICAL ANALGESIC

Roll On

No Mess

For arthritis, back pain,

sore muscles & joints
Soothing menthol
Paraben free

Lavender

scent

2.5 FL OZ (74 mL)

Advanced Ingredient Data

[{"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "36", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARCTIUM LAPPA ROOT", "unii": "597E9BI3Z3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA FLOWER", "unii": "OZ0E5Y15PZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "INDIAN FRANKINCENSE", "unii": "4PW41QCO2M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GREEN TEA LEAF", "unii": "W2ZU1RY8B0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ILEX PARAGUARIENSIS LEAF", "unii": "1Q953B4O4F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "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": "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 Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Ilex Paraguariensis 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 of 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 WALGREENS PHARMACIST RECOMMENDED Compare to the active ingredient in Biofreeze ® Overnight Gel †† OVERNIGHT Cold Therapy Pain Relief Gel MENTHOL 4%/TOPICAL ANALGESIC For arthritis, back pain, sore muscles & joints Soothing menthol Paraben free Lavender scent 3 FL OZ (89 mL)", "Principal Display Panel – 74 mL Bottle Label": "Walgreens WALGREENS PHARMACIST RECOMMENDED Compare to the active ingredient in Biofreeze ® Roll-On †† OVERNIGHT Cold Therapy Pain Relief MENTHOL 4%/TOPICAL ANALGESIC Roll On No Mess For arthritis, back pain, sore muscles & joints Soothing menthol Paraben free Lavender 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