MedPath

Target Sensitive Whitening TP

5820081 Target Sensitive Whitening TP (8015201)

Approved
Approval ID

ab9a129e-337b-31fe-e053-2995a90ac691

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 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.

Sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11673-237
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (14)

HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM NITRATEActive
Quantity: 5 g in 100 g
Code: RU45X2JN0Z
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.24 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIM
SODIUM TRIPOLYPHOSPHATE ANHYDROUSInactive
Code: 9SW4PFD2FZ
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM METHYL COCOYL TAURATEInactive
Code: JVL98CG53G
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/29/2020

Tube Artwork

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/29/2020

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact * aids in the prevention of dental cavities

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/29/2020

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/29/2020

Antihypersensitivity

Anticavity

WARNINGS SECTION

LOINC: 34071-1Updated: 7/29/2020

When using this product, if irritation occurs discontinue use. Stop use and ask a doctor if * the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. * pain/sensitivity still persists after 4 weeks of use.

KEEP OUT OF REACH OF CHILDREN. If more than is used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/29/2020

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 one minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. * children under 12 years of age: Consult a dentist or doctor.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/29/2020

store below 30C (86F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/29/2020

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocomidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

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Target Sensitive Whitening TP - FDA Drug Approval Details