Whitening .14 g/100g
Monofluorophosphate · PASTE, DENTIFRICE · Target
Whitening is a paste, dentifrice containing monofluorophosphate at .14 g/100g, taken dental. Manufactured by Target.
Key Facts
- Brand Name
- Whitening
- Generic Name
- Monofluorophosphate
- NDC Code (Product)
11673-385- Manufacturer
- Target
- Strength
- .14 g/100g
- Dosage Form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Marketing Status
- Application #
- M021
- Marketing Start
- 02/10/2024
Recall History
Flawless Beauty LLC
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
The Procter & Gamble Company
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
GOLD STAR DISTRIBUTION INC
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Family Dollar Stores, Llc.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Flawless Beauty LLC
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
GSK Consumer Healthcare
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Estee Lauder Inc
Stability Data Does Not Support Expiry
Flawless Beauty LLC
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Flawless Beauty LLC
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses aids in the prevention of dental cavities
Dosage & Administration
Directions adults and children 2 years of age and older: brush teeth thoroughly, preferably after ach meal or at least twice per day, or as directed by a dentist or doctor. instruct children under 6 years of age 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.
Warnings
Warnings Keep out of reach of children under 6 years of age . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Frequently Asked Questions
What is Whitening used for?
Whitening contains Monofluorophosphate. It is a paste, dentifrice taken dental. Consult your doctor for specific uses.
Is Whitening a controlled substance?
Whitening is not classified as a controlled substance by the DEA.
What is the generic name for Whitening?
The generic name for Whitening is Monofluorophosphate. There are no other listed brand versions of Monofluorophosphate.
What is the NDC code for Whitening .14 g/100g?
The NDC (National Drug Code) for Whitening .14 g/100g is 11673-385, listed by Target.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)