AQUAFRESH WHITENING  INTENSE WHITE- sodium fluoride paste 
AQUAFRESH WHITENING  WHITE AND SHINE- sodium fluoride paste 
Haleon US Holdings LLC

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Drug Facts

Purpose

Oral, helps prevents cavity

Directions

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

Warnings

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.

Active ingredient

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

Contains Sodium Fluoride

Inactive ingredients

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

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

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
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0614
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0614-011 in 1 CARTON06/27/2016
1121.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only06/27/2016
AQUAFRESH WHITENING   WHITE AND SHINE
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0613
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0613-011 in 1 CARTON06/27/2016
1121.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only06/27/2016
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: 16d84389-1ade-fd15-e063-6394a90ac3c8
Set id: 8baed730-f9a1-40ea-83fc-dcc6bd0ac62f
Version: 4
Effective Time: 20240424
 
Haleon US Holdings LLC