Spotlight Oral Care Kit For Bad Breath
Kit For Bad Breath
Oral Spotlight Care Inc
Human Otc Drug
NDC 75065-010Spotlight Oral Care Kit For Bad Breath also known as Kit For Bad Breath is a human otc drug labeled by 'Oral Spotlight Care Inc'. National Drug Code (NDC) number for Spotlight Oral Care Kit For Bad Breath is 75065-010. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Spotlight Oral Care Kit For Bad Breath drug includes . The currest status of Spotlight Oral Care Kit For Bad Breath drug is Active.
Drug Information:
| Drug NDC: | 75065-010 |
| 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: | Spotlight Oral Care Kit For Bad Breath |
| 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: | Kit For Bad Breath |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Oral Spotlight Care 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 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: | 28 Jun, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| 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: | part355 |
| 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: | 22 Dec, 2025 |
| 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: | Oral Spotlight Care Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 240698
416783
|
| 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 |
|---|
| 75065-010-05 | 1 KIT in 1 PACKAGE (75065-010-05) * 30 mL in 1 BOTTLE (75065-012-03) * 20 mL in 1 BOTTLE, SPRAY * 1 TUBE in 1 CARTON (75065-006-02) / 100 g in 1 TUBE | 28 Jun, 2021 | 31 Dec, 2023 | 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 anticavity
Product Elements:
Spotlight oral care kit for bad breath kit for bad breath spotlight oral care for gum health sodium fluoride sodium fluoride fluoride ion sorbitol water hydrated silica glycerin sodium bicarbonate sodium tripolyphosphate anhydrous cocamidopropyl betaine carboxymethylcellulose sodium, unspecified titanium dioxide zinc lactate anticavity fluoride foaming mouthwash for bad breath sodium fluoride sodium fluoride fluoride ion water xylitol glycerin poloxamer 407 cocamidopropyl betaine mentha arvensis leaf oil saccharin sodium tocopherol zinc citrate sodium chloride benzoic acid benzyl alcohol mouth spray for bad breath
Indications and Usage:
Use aids in the prevention of dental decay.
Warnings:
Warnings
Dosage and Administration:
Directions (anticavuty toothpaste only) adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. children under 6 years of age instruct in good brushing and rinsing habits (to minimize swallowing), supervise children as necessary until capable of using without supervision. children under 2 years of age consult a dentist or doctor. directions (foaming anticavity mouthwash for bad breath only) adults and children 6 years of age and older use once a day after brushing your teeth with a toothbrush. vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. do not swallow the rinse. do not eat or drink for 30 minutes after rinsing. children under 12 years of age instruct in good brushing and rinsing habits (to minimize swallowing), supervise children as necessary until capable of using without supervision. children under 6 years of age consult a dentist or
Read more...doctor.
Package Label Principal Display Panel:
Kit for bad breath labeling spotlight oral care b kit for bad breath contains sodium fluoride fluoride anticavitytoothpaste netwt. 3.5 oz (100 g) + auoride anticavity foaming mouthwash for bad breath1fl oz (30 ml)+ mouth sprayfor bad breath 0.7ft oz (20 ml) made in the usa distributed by spotlight oral care inc, 90 south dale, suite #8, saint paul, minnesota, usa 55102 res badbreath kit label 006 tube badbreath kit m-wash spray for badbreath
Further Questions:
Questions? +1 (646) 9806461