Biofreeze ® Overnight Roll-on

Biofreeze ® Overnight Roll-on
SPL v2
SPL
SPL Set ID f67d7b7a-8922-73f6-e053-2995a90a2e80
Route
TOPICAL
Published
Effective Date 2023-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Calendula Officinalis Flower Glycerin Green Tea Leaf Frankincense Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Melissa Officinalis Leaf Alcohol Arnica Montana Flower Aloe Vera Leaf Arctium Lappa Root Isopropyl Alcohol Water Silicon Dioxide Ilex Paraguariensis Leaf .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-16

Description

Mentol USP 4%

Purpose

Pain Relieving Gel


Medication Information

Purpose

Pain Relieving Gel

Description

Mentol USP 4%

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

■simple backache

■arthritis

■strains

■bruises

■sprains

Active

Mentol USP 4%

Section 50565-1

Keep out of reach of children:

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

For external use only.

Flammable: Keep away from excessive heat or open flame

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 ■children 2 years to under 12 years of age: use only under adult supervision

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.

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

Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Colloidal Silicon Dioxide, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine

Questions Or Comments

1-800-246-3733

Spl Unclassified Section

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

Principal Display Panel 74 Ml Bottle Label

CLINICALLY RECOMMENDED

NDC 59316-207-14

BIOFREEZE

COOL THE PAIN

ROLL-ON

MENTHOL- PAIN RELIEVING GEL

2.5 FL OZ (74mL)

SHAKE WELL BEFORE EACH USE


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

■simple backache

■arthritis

■strains

■bruises

■sprains

Active

Mentol USP 4%

Section 50565-1 (50565-1)

Keep out of reach of children:

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

Pain Relieving Gel

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

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 ■children 2 years to under 12 years of age: use only under adult supervision

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.

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

Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Colloidal Silicon Dioxide, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine

Questions Or Comments (Questions or Comments)

1-800-246-3733

Spl Unclassified Section (SPL UNCLASSIFIED SECTION)

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

Principal Display Panel 74 Ml Bottle Label (Principal Display Panel - 74 mL Bottle Label)

CLINICALLY RECOMMENDED

NDC 59316-207-14

BIOFREEZE

COOL THE PAIN

ROLL-ON

MENTHOL- PAIN RELIEVING GEL

2.5 FL OZ (74mL)

SHAKE WELL BEFORE EACH USE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)