Biofreeze ®

Biofreeze ®
SPL v6
SPL
SPL Set ID 890191e8-99ad-489c-8f21-2592f3d31936
Route
TOPICAL
Published
Effective Date 2022-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (70 mg)
Inactive Ingredients
Alcohol Aloe Vera Leaf Arctium Lappa Root Arnica Montana Flower Bis-peg-10 Dimethicone/dimer Dilinoleate Copolymer Frankincense Calendula Officinalis Flower Green Tea Leaf Hydroxyethyl Cetyldimonium Phosphate Ilex Paraguariensis Leaf Isopropyl Palmitate Melissa Officinalis Leaf Peg-12 Dimethicone (300 Cst) Pentylene Glycol Ppg-24-glycereth-24 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-27
Description

Drug Facts

Purpose

Pain Relieving Liquid

Medication Information

Purpose

Pain Relieving Liquid

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

Directions
  • adults and children 12 years of age and older: rub a thin film 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 7%

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

Alcohol Denat., Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Bis-PEG-10 Dimethicone, Boswellia Carterii Resin Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Hydroxyethyl Cetyldimonium Phosphate, Ilex Paraguariensis Leaf Extract, Isopropyl Palmitate, Melissa Officinalis Leaf Extract, PEG-12 Dimethicone, Pentylene Glycol, PPG-24-Glycereth-24, Water

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 88 Ml Bottle Label

CLINICALLY

RECOMMENDED

NDC 59316-991-10

BIOFREEZE ®

COOL THE PAIN

FAST

DRY

FOAM

MENTHOL-PAIN

RELIEVING LIQUID

  • RUBS IN EASILY
  • LIGHTWEIGHT FEEL
  • DRIES QUICKLY

3 FL OZ (88 mL)

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 Liquid

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

Directions
  • adults and children 12 years of age and older: rub a thin film 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 7%

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 Denat., Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Bis-PEG-10 Dimethicone, Boswellia Carterii Resin Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Hydroxyethyl Cetyldimonium Phosphate, Ilex Paraguariensis Leaf Extract, Isopropyl Palmitate, Melissa Officinalis Leaf Extract, PEG-12 Dimethicone, Pentylene Glycol, PPG-24-Glycereth-24, Water

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 88 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label)

CLINICALLY

RECOMMENDED

NDC 59316-991-10

BIOFREEZE ®

COOL THE PAIN

FAST

DRY

FOAM

MENTHOL-PAIN

RELIEVING LIQUID

  • RUBS IN EASILY
  • LIGHTWEIGHT FEEL
  • DRIES QUICKLY

3 FL OZ (88 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:05.855403 · Updated: 2026-03-14T23:06:25.914429