MedPath

Sensitivity and Gum

5820069 Rexall Sensitivity & Gum

Approved
Approval ID

039c6e46-f995-c744-e063-6294a90a537e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

DG Health (Rexall)

DUNS: 068331990

Products 1

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

Stannous Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55910-569
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Stannous Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (10)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUSInactive
Code: 9SW4PFD2FZ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STANNOUS FLUORIDEActive
Quantity: 0.15 g in 100 g
Code: 3FTR44B32Q
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/30/2023

Principal Display Panel

Carton R1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/30/2023

Uses

aids in the prevention of dental cavities * helps interfere with the harmful effects of plaque associated with gingivitis * builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/30/2023

Inactive ingredients

glycerin, water, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium saccharin

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/30/2023

Active ingredient

Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/30/2023

Purpose

Anticavity, Antigingivitis, Antihypersensitivity

WARNINGS SECTION

LOINC: 34071-1Updated: 11/30/2023

Warnings

When using this product, if irritation occurs discontinue use.

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 * pain/sensitivity still persists after 4 weeks of use * gingivitis, bleeding, or redness persists for more than 2 weeks * you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/30/2023

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: 11/30/2023

Directions

adults and children 12 years of age and older: apply at least a 1-inch strip of the product unto a soft bristle toothbrush * brush teeth thoroughly for at least 1 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: 11/30/2023

Other information

products containing stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. * this product is specifically formulated to help prevent staining. * store below 30C (86F)

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Sensitivity and Gum - FDA Drug Approval Details