Label: BLANX WHITE SHOCK WHITE AND PROTECT- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 70781-005-01 - Packager: Coswell Spa
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 4, 2019
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- ACTIVE INGREDIENT
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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.
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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.
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- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BLANX WHITE SHOCK WHITE AND PROTECT
sodium monofluorophosphate pasteProduct 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)