BLANX ADVANCED WHITENING- sodium monofluorophosphate, sodium fluoride paste

BlanX Advanced Whitening by

Drug Labeling and Warnings

BlanX Advanced Whitening by is a Otc medication manufactured, distributed, or labeled by Coswell Spa, Incos Cosmeceutica Industriale Srl. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Contains:

Sodium Monofluorophosphate 0.4% (528 ppm F)

Sodium Fluoride 0.08% (362 ppm F)

INACTIVE INGREDIENT

Ingredients:

Aqua, Glycerin, Hydrated Silica, Sorbitol, Silica, Cellulose Gum, Aroma, Xylitol, Cetraria Islandica Extract, Sodium Monofluorophosphate, Sodium Fluoride, Sodium Saccharin, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocoyl Taurate, Sodium Benzoate, Phenoxyethanol, Benzyl Alcohol, Eugenol, Limonene, CI 77891.

PURPOSE

Non-Abrasive Whitening Toothpaste

Advanced Whitening

Cleans, protects and whitens

For daily use

Complete dental care with Arctic Lichen for natural whitening

BlanX Whitening toothpaste containing Arctic Lichen cleans without abrasiveness, restoring the teeth's original whiteness day by day without harming tooth enamel. Arctic Lichen attacks the bacteria that cause plaque, tartar and discolouring of the teeth.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

For daily use

INDICATIONS & USAGE

For daily use

WARNINGS

Warnings

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLANX ADVANCED WHITENING 
sodium monofluorophosphate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70781-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.08 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)
EUGENOL (UNII: 3T8H1794QW)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70781-004-01	75 g in 1 TUBE; Type 0: Not a Combination Product	04/26/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/26/2017

Labeler - Coswell Spa (429512304)

Establishment
Name	Address	ID/FEI	Business Operations
Incos Cosmeceutica Industriale Srl		434933032	manufacture(70781-004)