biofreeze ®

biofreeze ®
SPL v4
SPL
SPL Set ID 32450cbf-4ed4-402b-a30e-e08a17bba3fb
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 (100 mg)
Inactive Ingredients
medium-chain triglycerides caprylyl glycol cetostearyl alcohol dimethicone gluconolactone glycerin glyceryl monostearate hydroxyacetophenone ilex paraguariensis leaf iodopropynyl butylcarbamate phenoxyethanol polysorbate 60 sodium benzoate sodium hydroxide sodium stearoyl lactylate edetate sodium .alpha.-tocopherol acetate grape seed oil water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-03-12

Purpose

Pain Relieving Cream

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 Cream

Directions
  • adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • 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

Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, 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%

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 113.3 G Tube Label

CLINICALLY

RECOMMENDED*

NDC 59316-001-20

BiOFREEZE ®

COOL THE PAIN

FOOT CREAM

MENTHOL-PAIN

RELIEVING CREAM

Net wt 4 OZ (113.3 g)


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 Cream

Directions
  • adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • 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)

Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, 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%

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 113.3 G Tube Label (PRINCIPAL DISPLAY PANEL - 113.3 g Tube Label)

CLINICALLY

RECOMMENDED*

NDC 59316-001-20

BiOFREEZE ®

COOL THE PAIN

FOOT CREAM

MENTHOL-PAIN

RELIEVING CREAM

Net wt 4 OZ (113.3 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)