Biofreeze ®

Biofreeze ®
SPL v4
SPL
SPL Set ID 6ec26bae-e395-49aa-969e-8c653d6f0b27
Route
TOPICAL
Published
Effective Date 2022-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (56 mg)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Benzalkonium Chloride Frankincense Green Tea Leaf Carboxymethylcellulose Sodium, Unspecified Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Isopropyl Myristate Kaolin Tartaric Acid Lauralkonium Chloride Mineral Oil Nonoxynol-10 Petrolatum Polysorbate 80 Propylene Glycol Povidone, Unspecified Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-31

Description

Drug Facts

Purpose

Pain Relieving Patch


Medication Information

Purpose

Pain Relieving Patch

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.

Directions
  • adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area not more than 3 to 4 times daily.
  • do not stretch the patch during application as it should be comfortable and not tight
  • do not overwrap or wrap patches over themselves
  • for best adhesion: area should be clean, dry, and smooth
  • children under 12 years of age: consult a physician
  • wash hands after use with cool water
Active Ingredient

Menthol 5.6%

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

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Benzalkonium Chloride, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Isopropyl Myristate, Kaolin, L-Tartaric Acid, Lauralkonium Chloride, Mineral Oil, Nonoxynol-10, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, 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 4 Strip Carton

CLINICALLY

RECOMMENDED*

NDC 59316-004-04

BiOFREEZE ®

COOL THE PAIN

FLEXIBLE

RELIEF

STRIPS

MENTHOL-PAIN

RELIEVING PATCH

Designed to provide up to

8 hours of long lasting

pain relief

Strong adhesion to stay

through any movement

Optimal thickness for

comfort and flexiblity

4 STRIPS |

EXTRA

LONG

10 in x 2 in

(25.4 cm x 5 cm) each


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 Patch

Warnings

For external use only.

Directions
  • adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area not more than 3 to 4 times daily.
  • do not stretch the patch during application as it should be comfortable and not tight
  • do not overwrap or wrap patches over themselves
  • for best adhesion: area should be clean, dry, and smooth
  • children under 12 years of age: consult a physician
  • wash hands after use with cool water
Active Ingredient (Active ingredient)

Menthol 5.6%

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)

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Benzalkonium Chloride, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Isopropyl Myristate, Kaolin, L-Tartaric Acid, Lauralkonium Chloride, Mineral Oil, Nonoxynol-10, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, 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 4 Strip Carton (PRINCIPAL DISPLAY PANEL - 4 Strip Carton)

CLINICALLY

RECOMMENDED*

NDC 59316-004-04

BiOFREEZE ®

COOL THE PAIN

FLEXIBLE

RELIEF

STRIPS

MENTHOL-PAIN

RELIEVING PATCH

Designed to provide up to

8 hours of long lasting

pain relief

Strong adhesion to stay

through any movement

Optimal thickness for

comfort and flexiblity

4 STRIPS |

EXTRA

LONG

10 in x 2 in

(25.4 cm x 5 cm) each


Advanced Ingredient Data


Raw Label Data

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