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Product NDC Code | 71101-030 | ||||
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Drug Name | Healthwise capsaicin heat patch |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
Application Number | M017 | ||||
Labeler Name | Veridian Healthcare | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Capsaicin: 0.025%...........................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 for Use: Adults and Childrens 12 Years of Age or Over Clean and dry affected area; free of lotions, ointments and creams Carefully remove backing starting at a corner. Apply sticky side of patch to affected area Do not use more than one patch in an 8-hour period. Repeat as necessary. Maximum 3 patches per day Discard after signle use Children under 12 years of age: Consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene 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 relief of minor pain of muscles and joints associated with: Arthiritis Minor backache Strains Sprains Bruises
Purpose
Information about the drug product’s indications for use.Purpose Temporary relief of minor pain associated with: arthritis, minor backache, muscle strains, muschle sprains, bruises
Spl product data elements
Usually a list of ingredients in a drug product.HealthWise Capsaicin Heat Patch CAPSAICIN HYDROGENATED POLYDECENE (550 MW) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) LIQUID PETROLEUM STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) 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 label
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 with pain rubs, medicated lotions, creams or ointments 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, contact a poison control center (1-800-222-1222) 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 avoid storage in direct sunlight Protect patch from excessive moisture
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS call 1-866-326-1313
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: Stop use and ask a doctor if ■ skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur ■ condition worsens ■symptoms persist more than 7 days ■symptoms clear and reoccur 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 ■ avoid contact with eyes, mucous membranes or rashes ■ do not bandage tightly ■ discontinue use at least 1 hour before a bath or shower ■ do not use immediately after a bath or shower ■ do not microwave ■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
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.For External Use Only Allergy alert: if you are allergic or suspect you are allergic to the ingredients listed below, including chili perppers.. consults with your physician before use.
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