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Biofreeze - Medication Information

Product NDC Code 59316-114
Drug Name

Biofreeze

Type Brand
Active Ingredients
Menthol, unspecified form 105 mg/ml
Route TOPICAL
Dosage Form SPRAY
RxCUI drug identifier 1489073,
1489074
Application Number part348
Labeler Name RB Health (US) LLC
Packages
Package NDC Code Description
59316-114-10 89 ml in 1 bottle (59316-114-10)
59316-114-25 118 ml in 1 bottle, spray (59316-114-25)
59316-114-30 473 ml in 1 bottle, spray (59316-114-30)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Menthol 10.5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children 12 years of age and older: spray on to affected area not more than 3 to 4 times daily; massage not necessary children under 12 years of age: consult a physician wash hands after use with cool water

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Purpose

Information about the drug product’s indications for use.
Purpose Pain Relieving Spray

Spl product data elements

Usually a list of ingredients in a drug product.
Biofreeze MENTHOL MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALCOHOL ARNICA MONTANA FLOWER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CHAMOMILE DIMETHYL SULFONE ECHINACEA ANGUSTIFOLIA WHOLE ILEX PARAGUARIENSIS LEAF ISOPROPYL MYRISTATE JUNIPER BERRY WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label CLINICALLY RECOMMENDED* NDC 59316-114-25 BiOFREEZE ® COOL THE PAIN SPRAY MENTHOL-PAIN RELIEVING SPRAY 4 FL OZ (118 mL) 360° SPRAY PRESS DOWN FIRMLY TO ACTIVATE SPRAYER FOR FIRST USE Principal Display Panel - 118 mL Bottle Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Dist. by: RB Health (US), Parsippany, NJ 07054-0224

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-800-246-3733

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug 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

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20-25°C (68-77°F) store in a cool dry place away from direct sunlight

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only. Flammable: Keep away from excessive heat or open flame Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. 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 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API