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| Product NDC Code | 84680-529 | ||||
|---|---|---|---|---|---|
| Drug Name | Biosavia external analgesic pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 199870 | ||||
| Application Number | M017 | ||||
| Labeler Name | BIOSAVIA USA, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Capsaicin 0.025 % Purpose Topical Analgesic
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 apply liberally onto affected area not more than 3 to 4 times daily Massage evenly where needed until the gel is fully absorbed Massage your feet for a better sleep For a craneal massage, use on your head from your neck to your temples pressing all over your scalp massage on afected area for physical fatigue, swollen feet and legs
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, DMDM Hydantoin, Glycerin, Isopropyl Myristate, Mentha Piperita (Peppermint) Oil, Mineral Oil, Panax Ginseng Root Extract, PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, Red 40 (CI 16035), Sodium Hydroxide, Tetrasodium EDTA, Water (Aqua)
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 Temporaryly relieves minor aches and pains of muscles and joints associated with strains bruises sprains arthritis simple neck or back ache
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.BIOSAVIA External Analgesic Pain Relief CAPSAICIN ALOE VERA LEAF ARNICA MONTANA WHOLE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ORANGE OIL, COLD PRESSED DMDM HYDANTOIN GLYCERIN ISOPROPYL MYRISTATE PEPPERMINT OIL MINERAL OIL ASIAN GINSENG PEG-12 DIMETHICONE POLYOXYL 40 HYDROGENATED CASTOR OIL FD&C RED NO. 40 SODIUM HYDROXIDE EDETATE SODIUM WATER CAPSAICIN CAPSAICIN
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.Package Labeling: Label0
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
Other information Store between 20-25C (68-77 F) store in a cool dry place away from direct sun light
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on wounds or damaged skin use if you are allergic to any ingredients in this product
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 reach of children
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? (954) 588-9852
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 symptoms persist or get worse after than 7days swallowed
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 Avoid contact with the eyes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
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 Do not use on wounds or damaged skin use if you are allergic to any ingredients in this product When using this product Avoid contact with the eyes Stop use and ask a doctor if symptoms persist or get worse after than 7days swallowed If pregnant or breast-feeding, ask a health professional before use keep out reach of children
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