BLANX WHITE SHOCK- sodium monofluorophosphate hydroxyapatite cetraria islandica paste

BlanX White Shock by

Drug Labeling and Warnings

BlanX White Shock 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

ACTIVE INGREDIENT

SODIUM MONOFLUOROPHOSPHATE

INACTIVE INGREDIENT

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

PURPOSE

Naturally whitens and removes
bacteria that cause plaque and tooth decay

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

For best results use twice a day

INDICATIONS & USAGE

For best results apply twice a day

WARNINGS

WARNING..DO NOT SWALLOW

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLANX WHITE SHOCK 
sodium monofluorophosphate hydroxyapatite cetraria islandica paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70781-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.82 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
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
Color	blue (CI 42090)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70781-001-01	75 g in 1 TUBE; Type 0: Not a Combination Product	06/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/14/2016

Labeler - Coswell Spa (429512304)

Establishment
Name	Address	ID/FEI	Business Operations
Incos Cosmeceutica Industriale Srl		434933032	manufacture(70781-001)