Biofreeze ®

Biofreeze ®
SPL v14
SPL
SPL Set ID 00bba5d2-b0e0-701c-e063-6294a90a5741
Route
TOPICAL
Published
Effective Date 2022-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (105 mg)
Inactive Ingredients
Alcohol Arnica Montana Flower Calendula Officinalis Flower Tea Leaf Oil Chamomile Dimethyl Sulfone Echinacea Angustifolia Whole Ilex Paraguariensis Leaf Isopropyl Myristate Juniper Berry Water Denatonium Benzoate Glycerin Tert-butyl Alcohol Isopropyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01
Description

Drug Facts

Purpose

Pain Relieving Spray

Medication Information

Purpose

Pain Relieving Spray

Description

Drug Facts

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5

Drug Facts

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

Contents under pressure. Do not puncture or incinerate.

Do not store at temperature above 120°F.

Directions
  • adults and children 12 years of age and older: spray on to affected area not more than 3 to 4 times daily; massage not necessary
  • children under 12 years of age: consult a physician
  • wash hands after use with cool water
Active Ingredient

Menthol 10.5%

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

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis Flower Oil, Camellia Sinensis

Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Denatonium Benzoate, Echinacea

Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate,

Juniperus Communis Fruit Extract, Methylsulfonylmethane, PurifiedWater, Tert-Butyl Alcohol

Questions Or Comments?

1-800-246-3733

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
Principal Display Panel 118 Ml Bottle Label

CLINICALLY

RECOMMENDED*

NDC 59316-834-20

BiOFREEZE ®

PROFESSIONAL

SPRAY

MENTHOL-PAIN

RELIEVING SPRAY

4 FL OZ (118 mL)

360°

SPRAY

PRESS DOWN FIRMLY TO

ACTIVATE SPRAYER FOR FIRST USE

Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5 (42229-5)

Drug Facts

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

Pain Relieving Spray

Warnings

For external use only.

Flammable:Keep away from excessive heat or open flame

Contents under pressure. Do not puncture or incinerate.

Do not store at temperature above 120°F.

Directions
  • adults and children 12 years of age and older: spray on to affected area not more than 3 to 4 times daily; massage not necessary
  • children under 12 years of age: consult a physician
  • wash hands after use with cool water
Active Ingredient (Active ingredient)

Menthol 10.5%

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)

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis Flower Oil, Camellia Sinensis

Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Denatonium Benzoate, Echinacea

Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate,

Juniperus Communis Fruit Extract, Methylsulfonylmethane, PurifiedWater, Tert-Butyl Alcohol

Questions Or Comments? (Questions or comments?)

1-800-246-3733

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
Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

CLINICALLY

RECOMMENDED*

NDC 59316-834-20

BiOFREEZE ®

PROFESSIONAL

SPRAY

MENTHOL-PAIN

RELIEVING SPRAY

4 FL OZ (118 mL)

360°

SPRAY

PRESS DOWN FIRMLY TO

ACTIVATE SPRAYER FOR FIRST USE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:29.401452 · Updated: 2026-03-14T23:07:22.014703