Label: AQUAFRESH WHITENING INTENSE WHITE- sodium fluoride paste
AQUAFRESH WHITENING WHITE AND SHINE- sodium fluoride paste
- NDC Code(s): 0135-0613-01, 0135-0614-01
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated April 24, 2024
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- Active ingredient
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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
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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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INGREDIENTS AND APPEARANCE
AQUAFRESH WHITENING INTENSE WHITE
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0614 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0614-01 1 in 1 CARTON 06/27/2016 1 121.9 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 06/27/2016 AQUAFRESH WHITENING WHITE AND SHINE
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0613 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0613-01 1 in 1 CARTON 06/27/2016 1 121.9 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 06/27/2016 Labeler - Haleon US Holdings LLC (079944263)
