BLANX WHITE SHOCK- sodium monofluorophosphate hydroxyapatite cetraria islandica 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.

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BlanX White Shock

ACTIVE INGREDIENT

SODIUM MONOFLUOROPHOSPHATE

INACTIVE INGREDIENTS

CETRARIA ISLANDICA EXTRACT

AQUA

HYDROXYPATITE

SORBITOL

HYDRATED SILICA

GLYCERIN

SILICA

ISOPROPYL ALCOHOL

SODIUM LAURYL SULFATE

CELLULOSE GUM

AROMA

CI 77891

SODIUM SACCHARIN

PVM/MA COPOLYMER

SODIUM BENZOATE

BENZYL ALCOHOL

PHENOXYETHANOL

CI 42090

Naturally whitens and removes
bacteria that cause plaque and tooth decay

Keep out of reach of children

For best results use twice a day

For best results apply twice a day

WARNING..DO NOT SWALLOW

LABEL

BLANX WHITE SHOCK 
sodium monofluorophosphate hydroxyapatite cetraria islandica paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70781-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.82 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
Product Characteristics
Colorblue (CI 42090) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70781-002-0175 g in 1 TUBE; Type 0: Not a Combination Product08/26/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/14/2016
Labeler - Coswell Spa (429512304)
Establishment
NameAddressID/FEIBusiness Operations
Incos Cosmeceutica Industriale Srl434933032manufacture(70781-002)

Revised: 2/2019
Document Id: 8112ae06-06e2-55ff-e053-2991aa0a9706
Set id: 3afb5721-e5f4-3fbf-e054-00144ff88e88
Version: 3
Effective Time: 20190204
 
Coswell Spa