Kiss My Face Sensitive Fluoride-free Whitening - Citrus Mint
Potassium Nitrate
Windmill Health Products, Llc
Human Otc Drug
NDC 74154-015Kiss My Face Sensitive Fluoride-free Whitening - Citrus Mint also known as Potassium Nitrate is a human otc drug labeled by 'Windmill Health Products, Llc'. National Drug Code (NDC) number for Kiss My Face Sensitive Fluoride-free Whitening - Citrus Mint is 74154-015. This drug is available in dosage form of Paste, Dentifrice. The names of the active, medicinal ingredients in Kiss My Face Sensitive Fluoride-free Whitening - Citrus Mint drug includes Potassium Nitrate - .05 g/g . The currest status of Kiss My Face Sensitive Fluoride-free Whitening - Citrus Mint drug is Active.
Drug Information:
| Drug NDC: | 74154-015 |
| 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: | Kiss My Face Sensitive Fluoride-free Whitening - Citrus Mint |
| 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: | Potassium Nitrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Windmill Health Products, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Paste, Dentifrice |
| 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: | POTASSIUM NITRATE - .05 g/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
|
| 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: | 18 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | Windmill Health Products, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312544
|
| 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: | RU45X2JN0Z
|
| 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 |
|---|
| 74154-015-04 | 1 TUBE in 1 CARTON (74154-015-04) / 127 g in 1 TUBE | 18 Feb, 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 tooth desensitizer
Product Elements:
Kiss my face sensitive fluoride-free whitening - citrus mint potassium nitrate potassium nitrate nitrate ion sorbitol glycerin hydrated silica water xylitol aloe vera leaf cetraria islandica whole horse chestnut tea tree oil olea europaea leaf echinacea angustifolia whole stevia rebaudiuna leaf peppermint oil licorice xanthan gum menthol, unspecified form sodium methyl cocoyl taurate sodium lauroyl sarcosinate carboxymethylcellulose sodium, unspecified sodium copper chlorophyllin potassium sorbate
Indications and Usage:
Uses helps relieve sensitivity due to cold, heat, acid or sweets. aids in the prevention of plaque and tartar build-up.
Warnings:
Warnings sensitive teeth may indicate a serious problem that may need prompt care by a dentist. see your dentist if the problem persists or worsens. keep out of reach of children under 6 years of age. if you accidentally swallow more than used for brushing, contact a poison control center or seek professional assistance immediately.
Dosage and Administration:
Directions apply at least a 1 inch strip of the product onto a soft bristle toothbrush. brush teeth thoroughly for at least 1 minute twice a day or as recommended by a dentist or doctor. children under 6 years of age: consult a dentist or doctor.
Package Label Principal Display Panel:
Principal display panel - 127 g tube carton fluoride free whitening toothpaste kiss my face ® breath blasting freshness⢠sensitive protection for sensitive teeth & gums with tea tree oil, aloe & iceland moss citrus mint gel ⢠100% vegan ⢠triclosan & sls free ⢠bpa free ⢠no artificial colors or flavors net wt. 4.5 oz principal display panel - 127 g tube carton