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| Product NDC Code | 59316-230 | ||||
|---|---|---|---|---|---|
| Drug Name | Biofreeze dry stick |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M017 | ||||
| Labeler Name | RB Health (US) LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient: Menthol 15% Purpose: Pain Relieving Stick
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 Directions ■ adults and children 12 years of age and older: turn dial and apply a thin film by rubbing over 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 alpha-tocopherol acetate, arachidic acid, c15-19 alkane, hydrogenated castor oil, lauric acid, linoleic acid, linolenic acid, menthyl ethylamido oxalate, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, stearic acid
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 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.Active ingredient: Menthol 15% Purpose: Pain Relieving Stick
Spl product data elements
Usually a list of ingredients in a drug product.BioFreeze Dry Stick Menthol ARACHIDIC ACID C15-19 ALKANE HYDROGENATED CASTOR OIL OLEIC ACID LINOLEIC ACID MENTHOL MENTHOL PARAFFIN MENTHYL ETHYLAMIDO OXALATE PALMITIC ACID MYRISTIC ACID .ALPHA.-TOCOPHEROL ACETATE STEARIC ACID LAURIC ACID LINOLENIC ACID PETROLATUM
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.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
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.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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ store at 20-25°C (68-77°F) ■ store in a cool dry place away from direct sunlight
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
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
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