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| Product NDC Code | 72490-039 | ||||
|---|---|---|---|---|---|
| Drug Name | Nufabrx medicine infused ankle sleeve |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| Application Number | M017 | ||||
| Labeler Name | Nufabrx 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 Capsaicin (Nonivamide) 0.19%
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 clean and dry affected area remove sleeve from packaging and place on ankle maximum use of 10 hours per day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient acrylate copolymer
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 Temporary relieves minor pain associated with: arthritis ankle pain muscle strains sprains bruises cramps
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.Nufabrx Medicine Infused Ankle Sleeve Capsaicin BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) 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.Label Entire Label
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 children If swallowed, get medical help or contact a Poison Control Center right away.
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 conditions worsen severe skin irritation occurs pain persists for more than 7 days symptoms clear up and occur again within a few days
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 do not wear if you are allergic to any material in this product or chili peppers do not apply to wounds, damaged or irritated skin do not get into eyes or on mucous membranes do not use with heating pad or other external analgesic products a slight burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not use 1 hour prior to bathing or within 30 minutes after bathing
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. When using this product use only as directed do not wear if you are allergic to any material in this product or chili peppers do not apply to wounds, damaged or irritated skin do not get into eyes or on mucous membranes do not use with heating pad or other external analgesic products a slight burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not use 1 hour prior to bathing or within 30 minutes after bathing Stop use and ask a doctor if conditions worsen severe skin irritation occurs pain persists for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding Ask a health professional before use. Keep out of reach 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