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Product NDC Code | 63941-691 | ||||
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Drug Name | Best choice targeted warming capsaicin heat patch |
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Type | Brand | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 1043399 | ||||
Application Number | M017 | ||||
Labeler Name | Valu Merchandisers Company | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Capsaicin 0.025%
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 12 years of age and over: Clean and dry affected area, free of lotions, oitments 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 patch after single 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 C6-20 polyolefin, 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: arthritis, minor backache, strains, sprains and bruises
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.Best Choice Targeted Warming Capsaicin Heat Patch Capsaicin CAPSICUM CAPSICUM HYDROGENATED C6-20 POLYOLEFIN (100 CST) NATURAL LATEX RUBBER PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) LIQUID PETROLEUM STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW)
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 Panel Best Choice Targeted Warming Capsaicin Heat Patch.jpg
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. When using this product use only as directed avoid contact with the 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.
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.Allergy alert: If you are allergic or suspect you are allergic to the ingredients of this product, including chilli peppers, consult with your physician before use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Scan here for more product information. Call 1-844-292-1112 for more product information.
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 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 the 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Avoid storage in direct sunlight Protect patch 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 on wounds or damaged skin with pain rubs, medicated lotions, creams or ointments with a heating pad. When using this product use only as directed avoid contact with the 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. 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, contact a poison control center (1-800-222-1222) 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