biofreeze®

biofreeze®
SPL v4
SPL
SPL Set ID cc1cba14-da40-4d7d-b522-b5c648798e96
Route
topical
Published
Effective Date 2024-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (40 mg)
Inactive Ingredients
aloe barbadensis leaf juice powder arctium lappa root arnica montana flower frankincense calendula officinalis flower green tea leaf camphor (synthetic) carbomer glycerin ilex paraguariensis leaf isopropyl alcohol isopropyl myristate melissa officinalis leaf silica alpha-tocopherol acetate trolamine aqua

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-01-03

Purpose

Pain Relieving Gel

How Supplied

Product: 50090-6361 NDC: 50090-6361-0 89 mL in a BOTTLE

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 Gel

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
Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, 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

How Supplied

Product: 50090-6361

NDC: 50090-6361-0 89 mL in a BOTTLE

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 4%

Biofreeze Colorless
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, or in conditions affecting children under 12 years of age

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 Gel

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
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, 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

How Supplied (HOW SUPPLIED)

Product: 50090-6361

NDC: 50090-6361-0 89 mL in a BOTTLE

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 4%

Biofreeze Colorless (BIOFREEZE COLORLESS)
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, or in conditions affecting children under 12 years of age

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)