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Biofreeze professional colorless roll-on - Medication Information

Product NDC Code 59316-118
Drug Name

Biofreeze professional colorless roll-on

Type Brand
Active Ingredients
Menthol, unspecified form 50 mg/ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 415975,
1794892
Application Number part348
Labeler Name RB Health (US) LLC
Packages
Package NDC Code Description
59316-118-10 89 ml in 1 bottle (59316-118-10)
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Active ingredient

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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

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 Gel

Spl product data elements

Usually a list of ingredients in a drug product.
Biofreeze Professional Colorless Roll-On MENTHOL, UNSPECIFIED FORM 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 MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM

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 - 89 mL Bottle Label CLINICALLY RECOMMENDED* NDC 59316-118-10 SHAKE WELL BEFORE EACH USE BiOFREEZE ® PROFESSIONAL COLORLESS ROLL-ON MENTHOL-PAIN RELIEVING GEL 3 FL OZ (89 mL) PRINCIPAL DISPLAY PANEL - 89 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, or in conditions affecting children under 12 years of age

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 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.

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