Salonpas Pain Relief
Menthol, Methyl Salicylate
Hisamitsu Pharmaceutical Co., Inc.
Human Otc Drug
NDC 46581-675Salonpas Pain Relief also known as Menthol, Methyl Salicylate is a human otc drug labeled by 'Hisamitsu Pharmaceutical Co., Inc.'. National Drug Code (NDC) number for Salonpas Pain Relief is 46581-675. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Salonpas Pain Relief drug includes Menthol - 63 mg/1 Methyl Salicylate - 210 mg/1 . The currest status of Salonpas Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 46581-675 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Salonpas Pain Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Menthol, Methyl Salicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hisamitsu Pharmaceutical Co., Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MENTHOL - 63 mg/1
METHYL SALICYLATE - 210 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | PERCUTANEOUS
TOPICAL
TRANSDERMAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jun, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA022029 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Hisamitsu Pharmaceutical Co., Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 853146
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0346587615016
|
| UPC stands for Universal Product Code. |
| UNII: | L7T10EIP3A
LAV5U5022Y
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 46581-675-01 | 1 PATCH in 1 POUCH (46581-675-01) | 01 Aug, 2020 | N/A | No |
| 46581-675-09 | 3 POUCH in 1 BOX (46581-675-09) / 3 PATCH in 1 POUCH | 01 Jun, 2018 | N/A | No |
| 46581-675-99 | 1 PATCH in 1 POUCH (46581-675-99) | 15 May, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic
Product Elements:
Salonpas pain relief menthol, methyl salicylate menthol menthol methyl salicylate salicylic acid aluminum silicate mineral oil
Indications and Usage:
Uses temporarily relieves mild to moderate aches and pains of muscles and joints associated with: strains sprains simple backache arthritis bruises
Warnings:
Warnings for external use only stomach bleeding warning: this product contains an nsaid, which may cause stomach bleeding. the chance is small but higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an nsaid [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed do not use on the face or rashes on wouds or damaged skin if allergic to aspirin or other nsaids with a heating pad when sweating (such as from exercise or heat) any patch from a pouch that has been open for 14 or more days right before or after heart surgery ask a doctor before use if you are allergic to topical products the stomach bleeding warning applies to you you are taking a diuretic you have high blood pressure, heart disease, or kidney disease when using this product wash hands after applying or removing patch. av
Read more...oid contact with eyes. if eye contact occurs, rinse thoroughly with water. the risk of heart attack or stroke may increase if you use more than directed or for longer than directed stop use and ask a doctor if stomach pain or upset gets worse or lasts you feel faint, vomit blood, or have bloody or black stools. these are signs of stomach beeding. rash, itching or skin irritaion develops condition worsens symptoms last for more than 3 days symptoms clear up and occur again within a few days if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. if put in mouth, get medical help or contact a poison control center right away. package not child resistant. dispose of the used patches after folding sticky ends together.
Do Not Use:
Warnings for external use only stomach bleeding warning: this product contains an nsaid, which may cause stomach bleeding. the chance is small but higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an nsaid [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed do not use on the face or rashes on wouds or damaged skin if allergic to aspirin or other nsaids with a heating pad when sweating (such as from exercise or heat) any patch from a pouch that has been open for 14 or more days right before or after heart surgery ask a doctor before use if you are allergic to topical products the stomach bleeding warning applies to you you are taking a diuretic you have high blood pressure, heart disease, or kidney disease when using this product wash hands after applying or removing patch. avoid contact with eyes. if eye contact occurs, rinse thoroughly with water. the risk of heart attack or stroke may increase if you use more than directed or for longer than directed stop use and ask a doctor if stomach pain or upset gets worse or lasts you feel faint, vomit blood, or have bloody or black stools. these are signs of stomach beeding. rash, itching or skin irritaion develops condition worsens symptoms last for more than 3 days symptoms clear up and occur again within a few days if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. if put in mouth, get medical help or contact a poison control center right away. package not child resistant. dispose of the used patches after folding sticky ends together.
When Using:
When using this product wash hands after applying or removing patch. avoid contact with eyes. if eye contact occurs, rinse thoroughly with water. the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Dosage and Administration:
Directions adults 18 years and older: only use one patch at a time clean and dry affected area remove patch from backing film and apply to skin (see illustration) apply one patch to the affected area and leave in place for up to 8 to 12 hours if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours do not use more than 2 patches per day do not use for more than 3 days in a row the used patch should be removed from the skin when a new one is applied children under 18 years of age: do not use; this product has not been shown to work in children
Stop Use:
Stop use and ask a doctor if stomach pain or upset gets worse or lasts you feel faint, vomit blood, or have bloody or black stools. these are signs of stomach beeding. rash, itching or skin irritaion develops condition worsens symptoms last for more than 3 days symptoms clear up and occur again within a few days
Package Label Principal Display Panel:
Principal display panel large 3 15/16" x 5 1/2" hisamitsu ndc#46581-675-09 for temporary relief of mild to moderate pain backache sore muscle sprains bruises salonpas pain relief patch apply for 8 - 12 hours menthol 3% methyl salicylate 10% topical analgesic fda approved non-prescription pain relieving patch effectiveness confirmed in clinical trial 9 large patches 3 15/16" x 5 1/2" (10cm x 14cm) package not child resistant. keep out of reach of children. *do not use more than one salonpas patch at a time. see directions. image of 9-patch box label
Principal display panel cut open here ndc#46581-675-01 how to apply 1 peel the center film. 2 place on affected area. 3 slide a film. 4 slide the other film. salonpas pain relief patch apply for 8 - 12 hours menthol 3% methyl salicylate 10% topical analgesic fda approved non-prescription pain relieving patch effectiveness confirmed in clinical trial 1 large patch 3 15/16" x 5 1/2" (10cm x 14cm) *do not use more than one salonpas patch at a time. see directions. hisamitsu package not child resistant. keep out of reach of children. manufactured by hisamitsu pharmaceutical co., inc. 408, tashirodaikan-machi, tosu, saga, japan distributed by hisamitsu america, inc. florham park, nj 07932 made in japan image of 1-patch pouch label
Principal display panel large 3 15/16" x 5 1/2" hisamitsu ndc#46581-675-99 for temporary relief of mild to moderate pain backache sore muscle strains bruises how to apply 1 peel the center film. 2 place on affected area. 3 slide a film. 4 slide the other film. salonpas pain relief patch apply for 8 - 12 hours menthol 3% methyl salicylate 10% topical analgesic fda approved non-prescription pain relieving patch effectiveness confirmed in clinical trial 1 large patch 3 15/16" x 5 1/2" (10cm x 14cm) package not child resistant. keep out of reach of children. *do not use more than one salonpas patch at a time. see directions. manufactured by hisamitsu pharmaceutical co., inc. japan saga tosu made in japan distributed by hisamitsu america, inc. florham park, nj 07932 free sample not for re-sale image of 1-patch sample label
Further Questions:
Questions or comments? toll free 1-87-salonpas www.salonpas.us