Biofreeze Roll-On

Manufacturer: A-S Medication Solutions
Effective date: 2023-10-30
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:58:39

Label at a glance#

ProductBiofreeze Roll-On

Active ingredientMENTHOL

Label structure12 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

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

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-246-3733

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses

INDICATIONS & USAGE SECTION

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

simple backache
arthritis
strains
bruises
sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from excessive heat or open flame

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

Questions or comments?

OTC - QUESTIONS SECTION

1-800-246-3733

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-6358

NDC: 50090-6358-0 74 mL in a BOTTLE