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| Product NDC Code | 49873-608 | ||||
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| Drug Name | Satogesic hot |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1043399, 1994403 |
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| Application Number | M017 | ||||
| Labeler Name | Sato Pharmaceutical Co., Ltd. | ||||
| 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 ingredient Capsicum extract 0.04% (Containing 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 2 years of age and over: ■ strip off the polyethylene film and place adhesive pad over affected area ■ pad may be cut with scissors for small areas such as fingers ■ change pad 1 or 2 times a day ■ apply to affected area not more than 3 or 4 times daily ■ Children under 2 years of age: do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Butylparaben, carbomer, carboxymethylcellulose sodium, dried aluminum hydroxide gel, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, methylparaben, partially neutralized polyacrylate, polyethylene glycol 3000 hydrogenated castor oil, polyvinyl alcohol, purified water, sorbitol, titanium dioxide
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 relieves 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 Capsaicin External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Satogesic Hot capsaicin BUTYL ACRYLATE/METHACRYLIC ACID COPOLYMER (2% METHACRYLIC ACID) CARBOXYMETHYLCELLULOSE SODIUM POLYVINYL ALCOHOL SORBITOL GLYCERIN TITANIUM DIOXIDE EDETATE DISODIUM ALGELDRATE MALIC ACID WATER BUTYLPARABEN METHYLPARABEN POLYOXYL 60 HYDROGENATED CASTOR OIL CAPSAICIN CAPSAICIN CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)
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.Carton, Part A
Carton, Part B
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 on damaged, or irritated skin ■ on children under 12 years with arthritis-like conditions unless directed by a doctor
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ store unused pads in the pouch ■ reseal the pouch after opening and keep tightly closed
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 irritation develops ■ redness occurs ■ condition worsens ■ symptoms persist for more than 7 days ■ symptoms clear up and occur again withn 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 ■ avoid contact with eyes or mucous membranes ■ do not cover with any additional wrap
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 on damaged, or irritated skin ■ on children under 12 years with arthritis-like conditions unless directed by a doctor When using this product ■ avoid contact with eyes or mucous membranes ■ do not cover with any additional wrap Stop use and ask a doctor if ■ rash, itching or excessive irritation develops ■ redness occurs ■ condition worsens ■ symptoms persist for more than 7 days ■ symptoms clear up and occur again withn a few days 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