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AQUAFRESH whitening white and shine

Medically reviewed on June 27, 2016

Dosage form: paste
Ingredients: SODIUM FLUORIDE 1.5mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0613

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

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.

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AQUAFRESH WHITENING  WHITE AND SHINE
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0613
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
SODIUM TRIPOLYPHOSPHATE ANHYDROUS 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
XANTHAN GUM 
COCAMIDOPROPYL BETAINE 
CARRAGEENAN 
SACCHARIN SODIUM 
SODIUM HYDROXIDE 
HIGH DENSITY POLYETHYLENE 
Packaging
#Item CodePackage Description
1NDC:0135-0613-011 TUBE in 1 CARTON
1121.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only06/27/2016
AQUAFRESH WHITENING  INTENSE WHITE
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0614
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
SODIUM TRIPOLYPHOSPHATE ANHYDROUS 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
XANTHAN GUM 
COCAMIDOPROPYL BETAINE 
CARRAGEENAN 
SACCHARIN SODIUM 
SODIUM HYDROXIDE 
HIGH DENSITY POLYETHYLENE 
Packaging
#Item CodePackage Description
1NDC:0135-0614-011 TUBE in 1 CARTON
1121.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only06/27/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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