Aquafresh Extreme Clean Whitening Action
Sodium Fluoride
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0135-0234Aquafresh Extreme Clean Whitening Action also known as Sodium Fluoride is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Aquafresh Extreme Clean Whitening Action is 0135-0234. This drug is available in dosage form of Paste. The names of the active, medicinal ingredients in Aquafresh Extreme Clean Whitening Action drug includes Sodium Fluoride - 1.13 mg/g . The currest status of Aquafresh Extreme Clean Whitening Action drug is Active.
Drug Information:
| Drug NDC: | 0135-0234 |
| 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: | Aquafresh Extreme Clean Whitening Action |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Aquafresh |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | EXTREME CLEAN WHITENING ACTION |
| 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: | Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Paste |
| 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: | SODIUM FLUORIDE - 1.13 mg/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 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: | 25 Mar, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Jun, 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: | 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: | 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: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1044547
|
| 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: | 8ZYQ1474W7
|
| 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 |
|---|
| 0135-0234-06 | 1 TUBE in 1 CARTON (0135-0234-06) / 158.7 g in 1 TUBE | 25 Mar, 2011 | N/A | No |
| 0135-0234-08 | 2 TUBE in 1 CARTON (0135-0234-08) / 158.7 g in 1 TUBE | 25 Mar, 2011 | 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 anticavity
Product Elements:
Aquafresh extreme clean whitening action sodium fluoride sodium fluoride fluoride ion water hydrated silica sorbitol glycerin polyethylene glycol 400 sodium lauryl sulfate xanthan gum titanium dioxide cocamidopropyl betaine saccharin sodium d&c red no. 30 aquafresh extreme clean deep action sodium fluoride sodium fluoride fluoride ion water hydrated silica sorbitol glycerin polyethylene glycol 400 sodium lauryl sulfate xanthan gum cocamidopropyl betaine titanium dioxide saccharin sodium d&c red no. 30
Indications and Usage:
Use aids in the prevention of dental cavities
Warnings:
Warnings when using this product, if irritation occurs discontinue use keep out of reach of children under 6 years of age. if you accidentally swallow more than used for brushing, get medical help or contact a poison control center right away. keep out of reach of children under 6 years of age. (whitening multi action only) if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product, if irritation occurs discontinue use
Dosage and Administration:
Directions ⢠adults and children 2 years and older: ⢠apply toothpaste onto a toothbrush ⢠brush teeth thoroughly, preferably after each meal, or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. minimize swallowing. spit out after brushing. ⢠to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established ⢠children under 2 years consult a dentist or doctor
Package Label Principal Display Panel:
Principal display panel ndc 0135-0234-08 aquafresh ® fluoride toothpaste triple protection ® extreme clean ® with micro-active foaming action whitening action sugar acid protection** from fluoride mint blast helps restore natural whiteness twin value pack 2 tubes of 5.6 oz (158.7g) each total net wt 11.2 oz (317.4g) aquafresh ® extreme clean ® whitening action toothpaste creates micro-active foam which seeks out hard to reach places in your mouth and fights bad breath. it rinses clear and carefully polishes your teeth so after only one tube youâll be left with significantly cleaner, smoother, whiter teeth*. take the feeling of clean to the extreme! ® sugar acid protection** **with sugar acid protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack. triple protection ⢠healthy gumsâ ⢠strong teeth ⢠fresh breath â with twice daily brushing *vs a regular toothpaste always follow the label trademarks are owned by or licensed to the gsk group of companies. aquafresh, triple protection, the iconic nurdle device are trademarks of the gsk group of companies. gsk consumer healthcare warren, nj 07059 ©2015 gsk group of companies 1-800-897-5623 105517xa c:\users\jx336321\pictures\drug listing\105517xa_aquafresh extreme clean whitening action 0234_2 x 5.6 oz.jpg
Principal display panel ndc 0135-0432-02 aquafresh ® fluoride toothpaste triple protection ® extreme clean ® with micro-active foaming action + whitening deep action sugar acid protection** from fluoride mint zest for a whole mouth clean net wt 5.6 oz (158.7g) aquafresh ® extreme clean ® deep action toothpaste creates micro-active foam which seeks hard to reach places; in between teeth and even the back of your tongue and rinses clear to leave your teeth clean and smooth. enjoy a whole mouth clean. take the feeling of clean to the extreme! ® **with sugar acid protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack. healthy gums* strong teeth fresh breath *with twice daily brushing always follow the label aquafresh, triple protection, the iconic nurdle device are trademarks of the gsk group of companies. glaxosmithkline consumer healthcare, l.p. moon township, pa 15108 ©2015 gsk group of companies we value your feedback 1-800-897-5623 101883xd aquafresh extreme clean deep action 5.6 oz carton
Further Questions:
Questions or comments? call toll-free 1-800-897-5623 (english/spanish) weekdays