BLANX INTENSIVE STAIN REMOVAL- sodium monofluorophosphate, sodium fluoride paste 
Coswell Spa

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

BlanX Intensive Stain Removal

Contains:

Sodium Monofluorophosphate 0.4% (528 ppm F)

Sodium Fluoride 0.08% (362 ppm F)

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.

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

For daily use

For daily use

Warnings

image

BLANX INTENSIVE STAIN REMOVAL 
sodium monofluorophosphate, sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70781-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.002 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.01 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70781-003-0175 g in 1 TUBE; Type 0: Not a Combination Product04/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/26/2017
Labeler - Coswell Spa (429512304)
Establishment
NameAddressID/FEIBusiness Operations
Incos Cosmeceutica Industriale Srl434933032manufacture(70781-003)

Revised: 2/2019
Document Id: 8112ae06-06eb-55ff-e053-2991aa0a9706
Set id: 4e2543f3-9d26-3d96-e054-00144ff8d46c
Version: 3
Effective Time: 20190204
 
Coswell Spa