BLANX INTENSIVE STAIN REMOVAL- sodium monofluorophosphate, sodium fluoride paste

BlanX Intensive Stain Removal by

Drug Labeling and Warnings

BlanX Intensive Stain Removal 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, Xylitol, Aroma, Cetraria Islandica Extract, Usnea Barbata Extract, Bambusa Arundinacea Stem Extract, Sodium Monofluorophosphate, Sodium Fluoride, Mentha Piperita Oil, Papain, Sodium Saccharin, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocoyl Taurate, Sodium Benzoate, Phenoxyethanol, Benzyl Alcohol, Maltodextrin, Anethol, Menthol, Eugenol, Limonene, CI 77891.

PURPOSE

Non-Abrasive Whitening Toothpaste

Intensive Stain Removal

Removes stubborn stains

For daily use

Complete dental care with Arctic Lichen for natural whitening

BlanX Stain Prevention toothpaste containing Arctic Lichen cleans without abrasiveness, restoring the teeth's original whiteness day by day while combatin stains. Its unique formula enriched with microscopic bamboo powder removes stains and pigmentation due to smoking, food, beverages and plaque deposits.

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 INTENSIVE STAIN REMOVAL 
sodium monofluorophosphate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70781-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.002 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.01 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
ANETHOLE (UNII: Q3JEK5DO4K)
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)
BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)
PAPAIN (UNII: A236A06Y32)
USNEA BARBATA (UNII: D6DVA9TCAP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70781-003-01	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(70781-003)