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Biofreeze overnight relief - Medication Information

Product NDC Code 59316-005
Drug Name

Biofreeze overnight relief

Type Brand
Active Ingredients
Menthol, unspecified form .3 g/6g
Route TOPICAL
Dosage Form PATCH
RxCUI drug identifier 420222,
2109627
Application Number M017
Labeler Name RB Health (US) LLC
Packages
Package NDC Code Description
59316-005-03 6 g in 1 patch (59316-005-03)
59316-005-04 4 patch in 1 carton (59316-005-04) / 6 g in 1 patch
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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 12 years of age and older: Clean and dry affected area pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area not more than 3 to 4 times daily. 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 Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride, Lavender Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

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 Patch

Spl product data elements

Usually a list of ingredients in a drug product.
Biofreeze Overnight Relief Menthol, Unspecified Form BENZALKONIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM GLYCERIN KAOLIN LAURALKONIUM CHLORIDE LAVENDER OIL MINERAL OIL PETROLATUM POLYSORBATE 80 PROPYLENE GLYCOL POVIDONE, UNSPECIFIED TARTARIC ACID TITANIUM DIOXIDE WATER POLYACRYLIC ACID (450000 MW) SODIUM POLYACRYLATE (2500000 MW) 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 - 4 Patch Pouch Carton CLINICALLY RECOMMENDED NDC 59316-005-04 BIOFREEZE ® COOL THE PAIN OVERNIGHT RELIEF PATCHES MENTHOL-TOPICAL ANALGESIC Overnight pain relief patch Scented with lavender essential oil Designed to stay on through the night Optimal thickness is designed for comfort and flexibility 4 PATCHES 5.125 in x 2.6 in (13 cm x 6.6 cm) each Label 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 Made in China

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? 1-866-682-4639

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 symptons 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° (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. 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 symptons 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