MedPath

Whitening

5820082 Target Whitening Toothpaste (8070491)

Approved
Approval ID

0074630f-9d8d-9209-e063-6294a90a4f01

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jan 24, 2025

Manufacturers
FDA

Target

DUNS: 006961700

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Monofluorophosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11673-385
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Monofluorophosphate
Product Specifications
Route of AdministrationDENTAL
Effective DateJanuary 24, 2025
FDA Product Classification

INGREDIENTS (12)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SODIUM MONOFLUOROPHOSPHATEActive
Quantity: 0.14 g in 100 g
Code: C810JCZ56Q
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/28/2023

Principal Display Panel

Carton R1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/29/2023

Uses

aids in the prevention of dental cavities

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/29/2023

Active ingredient

Sodium monofluorophosphate 0.76% w/w (0.14% w/v fluoride ion)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/29/2023

Purpose

Anticavity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/29/2023

Keep out of reach of children

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/29/2023

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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/29/2023

Inactive ingredients

glycerin, hydrated silica, water, sorbitol, pentasodium triphosphate, PVP, titanium dioxide, cellulose gum, flavor, cocamidopropyl betaine, sodium lauryl sulfate, potassium sorbate, sorbic acid, potassium acesulfam, sucralose, sodium hydroxide

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 11/29/2023

WARNINGS SECTION

LOINC: 34071-1Updated: 11/29/2023

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.

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Whitening - FDA Drug Approval Details