Biofreeze ®

Biofreeze ®
SPL v3
SPL
SPL Set ID 3f2b1f48-2d78-4985-a046-9f72de5e1a9b
Route
TOPICAL
Published
Effective Date 2022-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (0.05 g)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Frankincense Green Tea Leaf Carboxymethylcellulose Sodium, Unspecified Dihydroxyaluminum Aminoacetate Ethylhexylglycerin Glycerin Iodopropynyl Butylcarbamate Kaolin Mineral Oil Phenoxyethanol Petrolatum Polyacrylic Acid (450000 Mw) Polysorbate 80 Propylene Glycol Povidone, Unspecified Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water 1,2-hexanediol

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-10

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.
  • children under 12 years of age: consult a physician
  • wash hands after use with cool water
Active Ingredient

Menthol 5%

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

1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

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 Kit Carton

CLINICALLY

RECOMMENDED*

NDC 59316-887-04

BiOFREEZE ®

COOL THE PAIN

EXTRA LARGE

PATCHES

MENTHOL-PAIN

RELIEVING PATCH

Designed to provide up to

8 hours of long lasting pain relief

Proven cold therapy formula for sore

muscles, simple backaches, and joint pain

Flexible fabric for superior performance and comfort

4 PATCHES | 2 SIZES

EXTRA LARGE

AND LONG

2 EXTRA LARGE 9.84 in x 5.5 in (25 cm x 14 cm) each

2 LONG 7.87 in x 3.94 in (20 cm x 10 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.
  • children under 12 years of age: consult a physician
  • wash hands after use with cool water
Active Ingredient (Active ingredient)

Menthol 5%

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)

1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

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 Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

CLINICALLY

RECOMMENDED*

NDC 59316-887-04

BiOFREEZE ®

COOL THE PAIN

EXTRA LARGE

PATCHES

MENTHOL-PAIN

RELIEVING PATCH

Designed to provide up to

8 hours of long lasting pain relief

Proven cold therapy formula for sore

muscles, simple backaches, and joint pain

Flexible fabric for superior performance and comfort

4 PATCHES | 2 SIZES

EXTRA LARGE

AND LONG

2 EXTRA LARGE 9.84 in x 5.5 in (25 cm x 14 cm) each

2 LONG 7.87 in x 3.94 in (20 cm x 10 cm) each


Advanced Ingredient Data


Raw Label Data

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