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| Product NDC Code | 46581-830 | ||||||||||
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| Drug Name | Salonpas lidocaine pain relieving |
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| Type | Brand | ||||||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | PERCUTANEOUS, TOPICAL, TRANSDERMAL | ||||||||||
| Dosage Form | PATCH | ||||||||||
| RxCUI drug identifier | 1737778 | ||||||||||
| Application Number | part348 | ||||||||||
| Labeler Name | Hisamitsu Pharmaceutical Co., Inc. | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine 4%
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 film from patch and apply to the skin (see illustration) apply to affected are not more than 3 to 4 times daily remove patch from the skin after at most 8-hour 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 aluminum silicate, dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, methylparaben, oleic acid, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water
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 pain
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Salonpas LIDOCAINE Pain Relieving Lidocaine LIDOCAINE LIDOCAINE ALUMINUM SILICATE DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM GELATIN GLYCERIN METHYLPARABEN OLEIC ACID PROPYLENE GLYCOL PROPYLPARABEN TARTARIC ACID TITANIUM DIOXIDE WATER
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 category* WORLD'S BRAND NO.1 Hisamitsu NDC#46581-830-06 Desensitize aggravated nerves for temporary relief of pain Back Neck Shoulders Knees and Elbows Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch APPLY FOR 8 HOURS MAXIMUM STRENGTH*1 Numbing Relief Unscented 6 PATCHES 3 15/16" X 5 1/2" (10cm X 14cm) MADE IN JAPAN image of 6-patch box label
Principal Display Panel CUT OPEN HERE NDC#46581-830-01 HOW TO APPLY 1 Pull apart. 2 Peel off one side of the film. 3 Place on affected area. 4 Peel off the remaining film. 5 Press patch thoroughly. Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch APPLY FOR 8 HOURS MAXIMUM STRENGTH*1 Numbing Relief Unscented 1 PATCH 3 15/16" X 5 1/2" (10cm X 14cm) Child-resistant packaging. Hisamitsu MADE IN JAPAN image of 1-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 more than one patch at a time on wounds or damaged skin with a heating pad if you are allergic to any igredients of this product
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 localized skin reactions occur, such as rash, itching, redness, irritaion, pain, swelling and blistering 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
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 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 more than one patch at a time on wounds or damaged skin with a heating pad if you are allergic to any igredients of this product When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly Stop use and ask a doctor if localized skin reactions occur, such as rash, itching, redness, irritaion, pain, swelling and blistering 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