Smartmouth Mouth Sore Zinc Activated Formula
Menthol, Unspecified Form
Triumph Pharmaceuticals Inc.
Human Otc Drug
NDC 76357-409Smartmouth Mouth Sore Zinc Activated Formula also known as Menthol, Unspecified Form is a human otc drug labeled by 'Triumph Pharmaceuticals Inc.'. National Drug Code (NDC) number for Smartmouth Mouth Sore Zinc Activated Formula is 76357-409. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Smartmouth Mouth Sore Zinc Activated Formula drug includes . The currest status of Smartmouth Mouth Sore Zinc Activated Formula drug is Active.
Drug Information:
| Drug NDC: | 76357-409 |
| 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: | Smartmouth Mouth Sore Zinc Activated Formula |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Smartmouth |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Mouth Sore Zinc Activated Formula |
| 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: | Menthol, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Triumph Pharmaceuticals Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 01 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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: | part356 |
| 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: | Triumph Pharmaceuticals Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2108024
|
| 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: | |
| 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 |
|---|
| 76357-409-16 | 1 KIT in 1 CELLO PACK (76357-409-16) * 237 mL in 1 BOTTLE, PLASTIC * 237 mL in 1 BOTTLE, PLASTIC | 01 Jan, 2022 | 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 oral pain reliever
Product Elements:
Smartmouth mouth sore zinc activated formula menthol, unspecified form smartmouth mouth sore solution 1 water sodium benzoate benzoic acid sodium chlorite clear water smartmouth mouth sore solution 2 menthol, unspecified form menthol, unspecified form menthol, unspecified form water sodium benzoate benzoic acid glycerin poloxamer 407 propylene glycol poloxamer 124 zinc chloride sodium saccharin sodium sodium chloride benzyl alcohol sorbitol aloe vera leaf peppermint oil smartmouth mouth sore zinc activated formula menthol, unspecified form smartmouth mouth sore solution 1 water sodium benzoate benzoic acid sodium chlorite clear water smartmouth mouth sore solution 2 menthol, unspecified form menthol, unspecified form menthol, unspecified form water sodium benzoate benzoic acid glycerin poloxamer 407 propylene glycol poloxamer 124 zinc chloride sodium saccharin sodium sodium chloride benzyl alcohol sorbitol aloe vera leaf peppermint oil smartmouth mouth sore zinc activated formula menthol, unspecified form smartmouth mouth sore solution 1 water sodium benzoate benzoic acid sodium chlorite clear water smartmouth mouth sore solution 2 menthol, unspecified form menthol, unspecified form menthol, unspecified form water sodium benzoate benzoic acid glycerin poloxamer 407 propylene glycol poloxamer 124 zinc chloride sodium saccharin sodium sodium chloride benzyl alcohol sorbitol aloe vera leaf peppermint oil
Indications and Usage:
Uses for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat. for the temporary relief of pain associated with: canker sores minor dental procedures minor irritation or injury of the mouth or gums minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Warnings:
Warnings do not use this product for more than 7 days unless directed by a dentist or healthcare provider when using this product do not swallow do not exceed recommended dosage stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days keep out of reach of children. if more than used for rinsing is accidentally swallowed, get medical help or contact a poison control center right away
Do Not Use:
Warnings do not use this product for more than 7 days unless directed by a dentist or healthcare provider when using this product do not swallow do not exceed recommended dosage stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days keep out of reach of children. if more than used for rinsing is accidentally swallowed, get medical help or contact a poison control center right away
When Using:
When using this product do not swallow do not exceed recommended dosage
Dosage and Administration:
Directions adults and children 12 years of age & older: swish 20ml of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. use up to 4 times daily or as directed by a dentist or doctor. children 6 years to under 12 years of age should be supervised in the use of this product. children under 6 years of age: do not use.
Stop Use:
Stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days
Package Label Principal Display Panel:
Principal display panel - 437 ml kit cello pack mixes to activate 2 powerful solutions smart mouth⢠mouth sore zinc activated oral rinse⢠24 hour bad breath prevention with a morning & evening rinse soothes oral pain & irritation for all mouth sores, canker sores and cheek bites relieves gum, braces and denture irritation zinc promotes oral health & boosts immunity cool mint ⢠16 fl. oz. (473 ml) ⢠alcohol free ⢠safe for people with diabetes principal display panel - 437 ml kit cello pack
Principal display panel - 296 ml kit cello pack mixes to activate 2 powerful solutions smart mouth⢠mouth sore zinc activated oral rinse⢠24 hour bad breath prevention with a morning & evening rinse soothes oral pain & irritation for all mouth sores, canker sores and cheek bites relieves gum, braces and denture irritation zinc promotes oral health & boosts immunity cool mint ⢠10 fl. oz. (296 ml) ⢠alcohol free ⢠safe for people with diabetes principal display panel - 296 ml kit cello pack
Principal display panel - 320 ml kit cello pack mixes to activate 2 powerful solutions smart mouth⢠mouth sore zinc activated oral rinse⢠24 hour bad breath prevention with a morning & evening rinse soothes oral pain & irritation for all mouth sores, canker sores and cheek bites relieves gum, braces and denture irritation zinc promotes oral health & boosts immunity cool mint ⢠10.82 fl. oz. (320 ml) ⢠alcohol free ⢠safe for people with diabetes principal display panel - 320 ml kit cello pack
Further Questions:
Questions? 1-800-492-7040