BLANX WHITE SHOCK WHITE AND PROTECT- sodium monofluorophosphate paste

BlanX White Shock White and Protect by

Drug Labeling and Warnings

BlanX White Shock White and Protect 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 0.72% (950ppm F)

*ActiluX®

INACTIVE INGREDIENT

Ingredients:

Aqua, Sorbitol, Hydrated Silica, Glycerin, Silica, Isopropyl Alcohol, Sodium Lauryl Sulfate, Cellulose Gum, Aroma, Hydroxyapatite*, Sodium Monofluorophosphate, PVM/MA Copolymer, Cetraria Islandica Extract, Sodium Saccharin, Sodium Benzoate, Phenoxyethanol, Benzyl Alcohol, Phenoxyethanol, CI 77891, CI 42090.

PURPOSE

Whitening and Antibacterial Action

The use of the BLANX LED helps to prevent gingivitis, halitosis and other common oral diseases

The only ActiluX® based toothpaste, the double patented innovation that whitens with light.

Now with Blue Formula for an immediate whitening effect*.

ActiluX® is deposited on teeth and remains active throughout the day. Gives teeth the natural whiteness thanks to the light action.

The use of the BlanX LED intensifies the antibacterial and hygiene action of the White Shock formula.

It helps to prevent cavities, gingivitis, halitosis and other common oral diseases.

Effectively removes the bacteria that causes plaque and cavities.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

For daily usage.

INDICATIONS & USAGE

For daily usage.

WARNINGS

Warnings

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLANX WHITE SHOCK WHITE AND PROTECT 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70781-005
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
COPOVIDONE (UNII: D9C330MD8B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70781-005-01	50 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(70781-005)