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Sinsinpas hot large - Medication Information

Product NDC Code 55264-110
Drug Name

Sinsinpas hot large

Type Brand
Active Ingredients
Capsaicin 30 mg/1
Route TOPICAL
Dosage Form PATCH
RxCUI drug identifier 1043399
Application Number M017
Labeler Name Sinsin Pharmaceutical Co., Ltd.
Packages
Package NDC Code Description
55264-110-01 1 patch in 1 pouch (55264-110-01) / 3 patch in 1 patch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients 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 no more than 3 to 4 times daily Remove patch from 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 butyl hydroxytoluene, glyceryl rosinate, isopropryl myristate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (YS resin), titanium oxide, 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 the 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.
SINSINPAS HOT LARGE Capsaicin TITANIUM DIOXIDE ZINC OXIDE POLYBUTENE (1400 MW) PEG-20 SORBITAN STEARATE POLYISOBUTYLENE (200000 MW) PROPYLENE CARBONATE BUTYLATED HYDROXYTOLUENE GLYCERYL ROSINATE ISOPROPYL MYRISTATE NATURAL LATEX RUBBER CALCIUM CARBONATE 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.
Principal Display Panel SINSINPAS CAPSAICIN LARGE

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Distributed by: SINSIN Pharm America Brea, CA 92821

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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Storage and handling

Information about safe storage and handling of the drug product.
Other information 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 do not use otherwise than 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 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