biofreeze ®

biofreeze ®
SPL v4
SPL
SPL Set ID b4cc1db5-a33f-17bc-e053-2995a90ab7eb
Route
topical
Published
Effective Date 2022-01-18
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 green tea leaf chamomile dimethyl sulfone echinacea angustifolia whole ilex paraguariensis leaf isopropyl myristate juniper berry water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-12-31

Purpose

Pain Relieving Liquid

Description

Drug Facts


Medication Information

Warnings

For external use only.

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Pain Relieving Liquid

Directions
  • adults and children 12 years of age and older: shake well before use. Press pen straight down onto affected area and hold until tip is fully soaked with liquid. Using light pressure, dab onto skin and let dry. Apply 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
Other Information
  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight
Inactive Ingredients

Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Description

Drug Facts

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.

Active Ingredient

Menthol 10.5%

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
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 34 Ml Bottle Carton

NDC 59316-830-38

BiOFREEZE ®

COOL THE PAIN

PRECISION RELIEF PEN

MENTHOL-PAIN RELIEVING LIQUID

1.15 FL OZ (34 mL)


Structured Label Content

Warnings

For external use only.

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Pain Relieving Liquid

Directions
  • adults and children 12 years of age and older: shake well before use. Press pen straight down onto affected area and hold until tip is fully soaked with liquid. Using light pressure, dab onto skin and let dry. Apply 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
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., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

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.

Active Ingredient (Active ingredient)

Menthol 10.5%

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
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 34 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 34 mL Bottle Carton)

NDC 59316-830-38

BiOFREEZE ®

COOL THE PAIN

PRECISION RELIEF PEN

MENTHOL-PAIN RELIEVING LIQUID

1.15 FL OZ (34 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)