AQUAFRESH whitening

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:11:26

Label at a glance#

ProductAQUAFRESH whitening intense white
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Dosage and administration

Brush teeth twice a day, and no more than three times, avoid swallowing. Spit out after brushing.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Oral, helps prevents cavity

Directions

DOSAGE & ADMINISTRATION SECTION

Brush teeth twice a day, and no more than three times, avoid swallowing. Spit out after brushing.

Warnings

WARNINGS SECTION

Always follow the label. Do not use in children under 7 years of age.

Like other toothpastes, discontinue use if irritation or adverse reaction occurs. Consult a dentist if using fluoride supplements.

Store below 30°C.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride (sodium fluoride 0.15%) (1150 ppm of ion).

Contains Sodium Fluoride

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water; Sorbitol; Hydrated Silica; Glycerin; Pentasodium Triphosphate; PEG-8; Sodium Lauryl Sulfate; Flavor*; Titanium Dioxide; Alumina; Xanthan Gum; Cocamidopropyl betaine; Carrageenan; Sodium Saccharin; Sodium Hydroxide; Polyethylene; CI42090; CI73360.

*Contains d-limonene.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0613-01

Aquafresh ®

whitening

Fluoride toothpaste

triple protection ®

New Formula

white & shine

Brighter teeth in 1 week*

NET WT 121.9g (4.3oz)

Brighter teeth in just 1 week, thanks to the toothpaste Aquafresh White & Shine. Clinically proven*. Helps keep your teeth whiter and brighter for longer. Lasting whitening.

Protection to keep your mouth healthy and happy

*Compared to a standard toothpaste, with regular brushing

Made in the United States of America by: GlaxoSmithKline LLC, East Durham, NY 12423. Aquafresh® is a trademark of the GlaxoSmithKline group of companies.

Imported and distributed by:

GlaxoSmithKline Argentina S.A.,C. Casares 3690, Victoria, Bs.As., Argentina. Legajo N° 6557. M.S. Resol. N° 155/98. For questions: 0800 888-6006

GlaxoSmithKline Brasil Ltda.,Est. dos Bandeirantes, 8464, Rio de Janeiro, RJ. CNPJ33.247.743/0001-10. AFE: 2000086 Proc.: 25351080153201313. SAC 0800 021 15 29.

GlaxoSmithKline Chile Farmaceutica Ltda.,Lo Boza 107, Modulo A-6, Pudahuel, Santiago, Chile. Reg. I.S.P. N° 299C-38/13. For questions: 800382900.

Andean Region:Hansa Ltda., La Paz, Bolivia.

GlaxoSmithKline Colombia S.A.,Bogota, D.C., Colombia. For questions: 01-8000-118686.

GlaxoSmithKline Ecuador S.A.,Quito, Ecuador.

GlaxoSmithKline Peru S.A.,Av. Javier Prado Oeste 995, Peru. RUC 20100123682.

GlaxoSmithKline Costa Rica S.A.,400 mts. East of the Circle La Bandera, Sabanilla highway, San Jose, Costa Rica. Tel: 506 22066000.

GlaxoSmithKline Paraguay S.A., G. Aranda 333, Paraguay. Distributed by Helsecke y Cia. S.A.C.I. Req. Sanit. N°.

GlaxoSmithKline Uruguay S.A.,Salto 1105 Montevideo, Uruguay. Imp. N°10. Ley 15443. Reg. MSP N°.

GlaxoSmithKline Venezuela C.A.,Caracas, Venezuela. Registered under MPPS bajo NSO-PC-E-45.970-VE. RIF: J-00021492-1. Panama. Nicaragua. El Salvador. Honduras. Guatemala. Dominican Rep.

102938XA

Aquafresh whitening White & Shine 4.3 oz (121.9 g) carton
Aquafresh whitening White & Shine 4.3 oz (121.9 g) carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0614-01

Aquafresh ®

whitening

Fluoride toothpaste

triple protection ®

New Formula

intense white

whiter teeth that last longer*

NET WT 121.9g (4.3oz)

Whiter teeth that last longer*. Smile with confidence in your visibly whiter teeth for longer-result clinically proven by Aquafresh Intense White*. Contains small particles to clean and visibly whiten your teeth. Creates a protective barrier that helps prevent movement and new stains.

Protection to keep your mouth healthy and happy

*Compared to a standard toothpaste, with regular brushing, as assessed by dentists.

Made in the United States of America by: GlaxoSmithKline LLC, East Durham, NY 12423. Aquafresh® is a trademark of the GlaxoSmithKline group of companies.

Imported and distributed by:

GlaxoSmithKline Argentina S.A.,C. Casares 3690, Victoria, Bs.As., Argentina. Legajo N° 6557. M.S. Resol. N° 155/98. For questions: 0800 888-6006

GlaxoSmithKline Brasil Ltda.,Est. dos Bandeirantes, 8464, Rio de Janeiro, RJ. CNPJ33.247.743/0001-10. AFE: 2000086 Proc.: 25351080153201313. SAC 0800 021 15 29.

GlaxoSmithKline Chile Farmaceutica Ltda.,Lo Boza 107, Modulo A-6, Pudahuel, Santiago, Chile. Reg. I.S.P. N° 299C-38/13. For questions: 800382900.

Andean Region:Hansa Ltda., La Paz, Bolivia.

GlaxoSmithKline Colombia S.A.,Bogota, D.C., Colombia. For questions: 01-8000-118686.

GlaxoSmithKline Ecuador S.A.,Quito, Ecuador.

GlaxoSmithKline Peru S.A.,Av. Javier Prado Oeste 995, Peru. RUC 20100123682.

GlaxoSmithKline Costa Rica S.A.,400 mts. East of the Circle La Bandera, Sabanilla highway, San Jose, Costa Rica. Tel: 506 22066000.

GlaxoSmithKline Paraguay S.A., G. Aranda 333, Paraguay. Distributed by Helsecke y Cia. S.A.C.I. Req. Sanit. N°.

GlaxoSmithKline Uruguay S.A.,Salto 1105 Montevideo, Uruguay. Imp. N°10. Ley 15443. Reg. MSP N°.

GlaxoSmithKline Venezuela C.A.,Caracas, Venezuela. Registered under MPPS bajo NSO-PC-E-45.970-VE. RIF: J-00021492-1. Panama. Nicaragua. El Salvador. Honduras. Guatemala. Dominican Rep.

We value your opinion

www.gsl.com102940XB

Aquafresh whitening Intense White 4.3 oz (121.9 g) carton
Aquafresh whitening Intense White 4.3 oz (121.9 g) carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0613-01AQUAFRESH whiteningwhite and shine121.9 g in 1 TUBEPASTE121.94
0135-0613-01AQUAFRESH whiteningwhite and shine1 in 1 CARTONPASTE14
0135-0614-01AQUAFRESH whiteningintense white1 in 1 CARTONPASTE14
0135-0614-01AQUAFRESH whiteningintense white121.9 g in 1 TUBEPASTE121.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0613AQUAFRESH WHITENING INTENSE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING WHITE AND SHINE (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]42 package rows20240426_8baed730-f9a1-40ea-83fc-dcc6bd0ac62f.zip
0135-0614AQUAFRESH WHITENING INTENSE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING WHITE AND SHINE (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]42 package rows20240426_8baed730-f9a1-40ea-83fc-dcc6bd0ac62f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06140135-0614-01
0135-06130135-0613-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
16d84389-1ade-fd15-e063-6394a90ac3c88baed730-f9a1-40ea-83fc-dcc6bd0ac62f2024-04-24WarningsExact identifier
spl id: 16d84389-1ade-fd15-e063-6394a90ac3c8
spl set id: 8baed730-f9a1-40ea-83fc-dcc6bd0ac62f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.