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| Product NDC Code | 72490-030 | ||||
|---|---|---|---|---|---|
| Drug Name | Nufabrx arm 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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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Capsaicin (Nonivamide) 0.20%
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 arm Maximum use of 10 hours per day Wash separately from other clothing Do not wear more than 6 days straight without doctor consent
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 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 For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises and sprains.
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 Arm Sleeve Capsaicin BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) CAPSAICIN CAPSAICIN Size: XL/XXL Nufabrx Arm Sleeve Capsaicin BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) CAPSAICIN CAPSAICIN Size: XS/S Nufabrx Arm Sleeve Capsaicin BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) CAPSAICIN CAPSAICIN Size: M/L
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 and Drug Facts Front Label 72490-028 72490-029 72490-030
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 If you are allergic to any ingredients of this product or chili peppers, contact a doctor before use (allergy alert) On wounds or damaged skin With, or at the same time as, other external analgesic products With a heating pad
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
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 doctor if Condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days Rash, itching or excessive skin irritation develops
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 You may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes) Do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise Use only as directed Avoid contact with eyes and mucous membranes or rashes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding Consult a healthcare professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information Avoid storing product in direct sunlight. Protect product from excessive moisture.
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 If you are allergic to any ingredients of this product or chili peppers, contact a doctor before use (allergy alert) On wounds or damaged skin With, or at the same time as, other external analgesic products With a heating pad When using this product You may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes) Do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise Use only as directed Avoid contact with eyes and mucous membranes or rashes Stop use and ask doctor if Condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days Rash, itching or excessive skin irritation develops If pregnant or breastfeeding Consult a healthcare 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