Biofreeze ®

Biofreeze ®
SPL v34
SPL
SPL Set ID 83d5c2f2-2413-4d28-83b2-0808d0917b4d
Route
TOPICAL
Published
Effective Date 2022-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (40 mg)
Inactive Ingredients
.alpha.-tocopherol Acetate Aloe Vera Leaf Arnica Montana Flower Arctium Lappa Root Frankincense Calendula Officinalis Flower Green Tea Leaf Camphor (synthetic) Glycerin Ilex Paraguariensis Leaf Isopropyl Alcohol Isopropyl Myristate Melissa Officinalis Leaf Silicon Dioxide Trolamine Water Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-03 Until 2025-12-31
Description

Menthol USP 4%

Purpose

Pain Relieving Gel

Medication Information

Purpose

Pain Relieving Gel

Description

Menthol USP 4%

Uses:

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

Section 42229-5

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

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
Other Information

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

Active Ingredients:



Menthol USP 4%

Inactive Ingredients:

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:

 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

If Pregnant Or Breastfeeding:

Ask a health professional before use

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

Keep Out of Reach of Children:

If swallowed, get medical help or contact a Poison Control Center right away

Principal Display Panel 473 Ml Bottle Label

CLINICALLY

RECOMMENDED ®

NDC 59316-102-30

BiOFREEZE ®

COOL THE PAIN

GEL

MENTHOL-PAIN

RELIEVING GEL

16 FL OZ (1 PT) 473 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)

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

Purpose

Pain Relieving Gel

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
Other Information (Other information)

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

Active Ingredients:



Menthol USP 4%

Inactive Ingredients:

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: (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

If Pregnant Or Breastfeeding: (If pregnant or breastfeeding:)

Ask a health professional before use

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

Keep Out of Reach of Children: (Keep out of reach of children:)

If swallowed, get medical help or contact a Poison Control Center right away

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

CLINICALLY

RECOMMENDED ®

NDC 59316-102-30

BiOFREEZE ®

COOL THE PAIN

GEL

MENTHOL-PAIN

RELIEVING GEL

16 FL OZ (1 PT) 473 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.715049 · Updated: 2026-03-14T23:01:49.492831