Biofreeze Professional Colorless Gel

Biofreeze Professional Colorless Gel
SPL v12
SPL
SPL Set ID 4639201c-a67a-475f-8df6-3dc6225803ad
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 (50 mg)
Inactive Ingredients
Aloe Vera Leaf Arctium Lappa Root Arnica Montana Flower Frankincense Calendula Officinalis Flower Green Tea Leaf Carbomer Homopolymer, Unspecified Type Glycerin Ilex Paraguariensis Leaf Isopropyl Alcohol Isopropyl Myristate Melissa Officinalis Leaf Silicon Dioxide .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-06-03 Until 2020-12-31

Description

Menthol USP 5%

Purpose

Pain Relieving Gel


Medication Information

Purpose

Pain Relieving Gel

Description

Menthol USP 5%

Uses:

Temporarily relieves from minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Directions:

• Adults and Children 2 years of age and older: Rub a thin film over affected areas 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

Active Ingredients:

Menthol USP 5%

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, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, 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, or in conditions affecting children under 12 years of age

If Pregnant Or Breast Feeding:

Ask a health professional before use

Keep Out of Reach of Children:

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel 946 Ml Bottle Label

CLINICALLY

RECOMMENDED*

BiOFREEZE ®

PROFESSIONAL

NDC 59316-116-40

COLORLESS GEL

MENTHOL-PAIN

RELIEVING GEL

32 FL OZ (1 QT) 946 mL


Structured Label Content

Uses:

Temporarily relieves from minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Purpose

Pain Relieving Gel

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Directions:

• Adults and Children 2 years of age and older: Rub a thin film over affected areas 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

Active Ingredients:

Menthol USP 5%

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, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, 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, or in conditions affecting children under 12 years of age

If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)

Ask a health professional before use

Keep Out of Reach of Children: (Keep out of reach of children:)

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel 946 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label)

CLINICALLY

RECOMMENDED*

BiOFREEZE ®

PROFESSIONAL

NDC 59316-116-40

COLORLESS GEL

MENTHOL-PAIN

RELIEVING GEL

32 FL OZ (1 QT) 946 mL


Advanced Ingredient Data


Raw Label Data

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