Leader Maximum Strength Pain Relieving Analgesic
Trolamine Salicylate
Cardinal Health, 110 Dba Leader
Human Otc Drug
NDC 70000-0169Leader Maximum Strength Pain Relieving Analgesic also known as Trolamine Salicylate is a human otc drug labeled by 'Cardinal Health, 110 Dba Leader'. National Drug Code (NDC) number for Leader Maximum Strength Pain Relieving Analgesic is 70000-0169. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Leader Maximum Strength Pain Relieving Analgesic drug includes Trolamine Salicylate - 100 mg/g . The currest status of Leader Maximum Strength Pain Relieving Analgesic drug is Active.
Drug Information:
| Drug NDC: | 70000-0169 |
| 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: | Leader Maximum Strength Pain Relieving Analgesic |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Leader Maximum Strength Pain Relieving |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Analgesic |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Trolamine Salicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health, 110 Dba Leader |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | TROLAMINE SALICYLATE - 100 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | OTC MONOGRAPH NOT FINAL |
| 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: | 31 Aug, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| 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: | part348 |
| 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: | Cardinal Health, 110 dba LEADER
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313518
|
| 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. |
| UNII: | H8O4040BHD
|
| 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 |
|---|
| 70000-0169-1 | 1 TUBE in 1 CARTON (70000-0169-1) / 85 g in 1 TUBE | 31 Aug, 2017 | 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:
Leader maximum strength pain relieving analgesic trolamine salicylate trolamine salicylate salicylic acid aloe vera leaf cetyl alcohol glycerin methylparaben mineral oil potassium phosphate, unspecified form propylparaben sodium hydroxide stearic acid water
Indications and Usage:
Uses temporarily relieves minor pain associated with: ? arthritis ? simple backache ? muscle strains ? sprains ? bruises ? cramps
Warnings:
Warnings for external use only allergy alert! if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. when using this product ? use only as directed. read an follow all directions and warnings on this label ? do not bandage tightly or apply local heat (such as heating pads) to the area of use ? avoid contact with eyes and mucous membranes ? do not apply to wounds or damaged, broken or irritated skin ? do not use at the same time as other topical analgesics stop use and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days ? redness is present ? irritation develops if you are pregnant or nursing a baby , seek the advice of a health professional before using this product. keep out of reach of children . if swallowed, get medical help or contact a poison control center immediately at 1-800-222-1222.
When Using:
When using this product ? use only as directed. read an follow all directions and warnings on this label ? do not bandage tightly or apply local heat (such as heating pads) to the area of use ? avoid contact with eyes and mucous membranes ? do not apply to wounds or damaged, broken or irritated skin ? do not use at the same time as other topical analgesics
Dosage and Administration:
Directions ? adults and children 12 years of age and older: apply to affected area not more than 4 times per day. massage into painful area until thoroughly absorbed into skin ? children under 12 years of age: do not use, consult a doctor
Stop Use:
Stop use and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days ? redness is present ? irritation develops
Package Label Principal Display Panel:
Principal display panel - 85 g tube carton maximum strength ndc 70000-0169-1 pain relieving cream trolamine salicylate, 10% topical analgesic rub temporary relief of minor muscle aches and pains associated with arthritis, simple backache or sprains fast acting odor free with aloe compare to aspercreme ® maximum strength active ingredients* 100% money back guarantee net wt 3 oz (85 g) principal display panel - 85 g tube carton
Further Questions:
Questions or comments? 1-866-567-8600