Spotlight Oral Care Kit For Sensitive Teeth
Kit For Sensitive Teeth
Oral Spotlight Care Inc
Human Otc Drug
NDC 75065-011Spotlight Oral Care Kit For Sensitive Teeth also known as Kit For Sensitive Teeth is a human otc drug labeled by 'Oral Spotlight Care Inc'. National Drug Code (NDC) number for Spotlight Oral Care Kit For Sensitive Teeth is 75065-011. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Spotlight Oral Care Kit For Sensitive Teeth drug includes . The currest status of Spotlight Oral Care Kit For Sensitive Teeth drug is Active.
Drug Information:
| Drug NDC: | 75065-011 |
| 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 Sensitive Teeth |
| 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 Sensitive Teeth |
| 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 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: | 02 Jul, 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: | 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: | 11 Jun, 2026 |
| 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
1038929
|
| 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 |
|---|
| 75065-011-05 | 1 KIT in 1 PACKAGE (75065-011-05) * 30 mL in 1 BOTTLE (75065-013-03) * 15 mL in 1 TUBE (75065-014-04) * 1 TUBE in 1 CARTON (75065-009-02) / 100 g in 1 TUBE | 02 Jul, 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 toothpaste only) potassium nitrate .......... for sensitive teeth sodium fluoride ............ anticavity (anticavity gel only) potassium nitrate .......... for sensitive teeth sodium fluoride ............ anticavity (foaming anticavity mouthwash) sodium fluoride ......... anticavity
Product Elements:
Spotlight oral care kit for sensitive teeth kit for sensitive teeth spotlight oral care for sensitive teeth potassium nitrate, sodium fluoride potassium nitrate nitrate ion sodium fluoride fluoride ion sorbitol water hydrated silica glycerin tricalcium phosphate xanthan gum cocamidopropyl betaine saccharin sodium sodium benzoate titanium dioxide anticavity fluoride foaming mouthwash for strengthening enamel sodium fluoride sodium fluoride fluoride ion water xylitol glycerin poloxamer 407 cocamidopropyl betaine mentha arvensis leaf oil tribasic calcium phosphate potassium citrate tocopherol saccharin sodium calcium gluconate sodium chloride sodium benzoate anticavity fluoride gel for sensitive teeth sodium fluoride sodium fluoride fluoride ion potassium nitrate nitrate ion water glycerin carboxymethylcellulose sodium, unspecified xylitol saccharin sodium sodium phosphate, monobasic, unspecified form hydrated silica
Indications and Usage:
Uses (anticavity toothpaste) â¢helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. ⢠builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. ⢠aids in the prevention of dental cavities. (anticavity gel) â¢helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. ⢠builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. ⢠aids in the prevention of dental cavities. use (foaming anticavity mouthwash) aids in the prevention of dental decay.
Warnings:
Warnings (anticavity toothpaste) when using this product do not use longer than 4 weeks unless recommended by a dentist or doctor. stop use and ask a dentist if the problem persists or worsens. sensitive teeth may indicate a serious problem that may need prompt care by a dentist. (anticavity gel) when using this product do not use longer than 4 weeks unless recommended by a dentist or doctor. stop use and ask a dentist if the problem persists or worsens. sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
Dosage and Administration:
Directions (anticavity toothpaste) ⢠adults and children 12 years of age and older: 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 (morning and evening) or as recommended by a dentist or doctor. ⢠make sure to brush all sensitive areas of the teeth. ⢠children under 12 years of age: consult a dentist or doctor. (anticavity gel) ⢠adults and children 12 years of age and older: 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 (morning and evening) or as recommended by a dentist or doctor. ⢠make sure to brush all sensitive areas of the teeth. ⢠children under 12 years of age: consult a dentist or doctor. (foaming anticavity mouthwash) directions adults and children 6 years of age and older use once a day after brushing your teeth with a toothpaste. vigorously swish 10 milliliters of rinse
Read more...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 doctor.
Package Label Principal Display Panel:
Kit for sensitive teeth labeling spotlight oral care s kit for sensitive teeth contains sodium fluoride potassium nitrate fluoride anticavitytoothpaste net wt. 3.5 oz (100 g) + fluoride anticavity foaming mouthwash for strengthening enamel 1 fl oz (30 ml)+ fluoride anticavity gel for sensitive teeth 0.5 fl oz (15 ml) made in the usa distributed by spotlight oral care inc, 90 south dale, suite #8, saint paul, minnesota, usa 55102 res kit lbl-sensteeth 009 tube gel for sensteth sensteth m-wash
Further Questions:
Questions or comments? +1 (646) 9806461