BIOFREEZE MENTHOL RB HEALTH (US) LLC FDA Approved Uses: Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains
Generic: MENTHOL

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients: Menthol USP 4% Purpose Pain Relieving Gel
Inactive Ingredients
Inactive Ingredients: Aloe Barbadensis Leaf Extract Arctium Lappa Root (Burdock) Extract Arnica Montana Flower Extract Blue 1 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 Yellow 5
Strengths
4 %
Quantities
473 ml
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Of Muscles And Joints Associated With Simple Backache Arthritis Strains Bruises Sprains

Identifiers & Packaging

Container Type BOTTLE
UNII
L7T10EIP3A
Packaging

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label CLINICALLY RECOMMENDED ® NDC 59316-102-30 BiOFREEZE ® COOL THE PAIN GEL MENTHOL-PAIN RELIEVING GEL 16 FL OZ (1 PT) 473 mL PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label CLINICALLY RECOMMENDED ® NDC 59316-102-30 BiOFREEZE ® COOL THE PAIN GEL MENTHOL-PAIN RELIEVING GEL 16 FL OZ (1 PT) 473 mL PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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 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 breastfeeding: 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
Purpose

Purpose Pain Relieving Gel

When Using

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 & Ask a Doctor

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

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

Storage & Handling

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

Questions

Questions or Comments: 1-800-246-3733


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