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| Product NDC Code | 63868-308 | ||||
|---|---|---|---|---|---|
| Drug Name | 2-count heat patches |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1043399 | ||||
| Application Number | part348 | ||||
| Labeler Name | QUALITY CHOICE (Chain Drug Marketing Association) | ||||
| 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 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: For Use on Adults and Childrens 12 Years of Age or Older Clean and dru affected area; ensure area is fully dry before application Remove patch from film Apply to treatement site Patch may be trimmerd to best fit treatment site; trim patch before removing film Wash hands after application Discard after signle use Caution: Take care when using on elderly ot incapacited persons Do not use more than 8 hours Do not use the Capsaicin Heat Patch more than 3-4 times daily Do not exceed 7 days of continue use
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 associated with: Arthiritis Minor backache Strains Sprains Bruises
Purpose
Information about the drug product’s indications for use.Purpose Temporary relief of minor pain.
Spl product data elements
Usually a list of ingredients in a drug product.2-Count HEAT PATCHES CAPSAICIN CAPSAICIN CAPSAICIN HYDROGENATED POLYDECENE (550 MW) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) LIQUID PETROLEUM STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)
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 Distributed by C.D.M.A., Inc. 43157 W. Nine Mile Novi, MI 48375 Made in China Capsaicin Heat Path
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 areas with sensitive skin, open wounds or previous burns with pain rubs, medicated lotions, creams or oinments with other forms of heat theraphy, including heating pads, or multiples of this treatment on a single treatement site Use Only as Directed: Follow the below directions for use. Avoid contact with eyes, mucus membrances or skin rashes. Stop Use immediately and Seek Medical Attention if: Rash, itching or excessive skin irritation develops Conditions worsens Symptons persist more than 7 days Symptoms clear, and reoccur within a few days
Use Only as Directed: Follow the below directions for use. Avoid contact with eyes, mucus membrances or skin rashes. Stop Use immediately and Seek Medical Attention if: Rash, itching or excessive skin irritation develops Conditions worsens Symptons persist more than 7 days Symptoms clear, and reoccur within a few days
Stop Use immediately and Seek Medical Attention if: Rash, itching or excessive skin irritation develops Conditions worsens Symptons persist more than 7 days Symptoms clear, and reoccur within a few days
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, contacr a poison control center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS Customer Care Help Line 248-449-9300 www.qualitychoice.com
Storage and handling
Information about safe storage and handling of the drug product.Storage and Care: One time use only; do not attempt to reuse the product 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.For External Use Only Discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming. 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