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Salonpas-hot capsicum - Medication Information

Product NDC Code 46581-700
Drug Name

Salonpas-hot capsicum

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]
Active Ingredients
Capsicum .025 g/100g
Route TOPICAL
Dosage Form PATCH
RxCUI drug identifier 1043399
Application Number M017
Labeler Name Hisamitsu Pharmaceutical Co., Inc.
Packages
Package NDC Code Description
46581-700-01 1 patch in 1 pouch (46581-700-01) / 4 g in 1 patch
46581-700-03 3 patch in 1 pouch (46581-700-03) / 4 g in 1 patch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Capsicum extract 0.025% as Capsaicin

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 remove patch from film apply to affected area not more than 3 to 4 times daily remove patch from the skin after at most 8 hours' application Children under 12 years of age: consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients butylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, natural rubber latex, polybutene, polyisobutylene, silicon dioxide, titanium dioxide, zinc oxide

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 temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises 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.
SALONPAS-HOT CAPSICUM Capsaicin CAPSICUM CAPSICUM CAPSAICIN BUTYLATED HYDROXYTOLUENE NATURAL LATEX RUBBER SILICON DIOXIDE TITANIUM DIOXIDE ZINC OXIDE

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 OTC topical analgesics in patch format* WORLD'S BRAND NO.1 Hisamitsu NDC#46581-700-01 for temporary relief of minor aches and pains of muscles and joints associated with Simple backache Arthritis Strains Bruises Sprains Salonpas-HOT CAPSICUM Patch Topical Analgesic 1 PATCH 5.12" X 7.09" (13cm X 18cm) MADE IN JAPAN image of 1-patch pouch label Principal Display Panel 3 LARGE FOLDED PATCHES 5.12" X 7.09"(13 cm X 18 cm) OTC topical analgesics in patch category* WORLD'S BRAND NO.1 Hisamitsu NDC#46581-700-03 for temporary relief of minor aches and pains of muscles and joints associated with Simple backache Arthritis Strains Bruises Sprains Salonpas-HOT CAPSICUM Patch Topical Analgesic 3 FOLDED PATCHES 5.12" X 7.09" (13cm X 18cm) MADE IN JAPAN image of 3-patch pouch 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 a heating pad if you are allergic to any ingredients of this 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

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Toll free 1-800-826-8861 www.salonpas.us

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 rash, itching or excessive skin irritation develops conditions worsen symptoms persist 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 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

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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 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 on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this 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 Stop use and ask a doctor if rash, itching or excessive skin irritation develops conditions worsen symptoms persist 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 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