BLANX WHITE SHOCK- sodium monofluorophosphate hydroxyapatite cetraria islandica paste

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Coswell Spa
INN (International Name):
SODIUM MONOFLUOROPHOSPHATE
Composition:
FLUORIDE ION 0.82 g in 100 g
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Naturally whitens and removes bacteria that cause plaque and tooth decay For best results apply twice a day
Authorization status:
OTC monograph final
Authorization number:
70781-001-01

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

BLANX WHITE SHOCK

sodium monofluorophosphate hydroxyapatite cetraria islandica paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 78 1-0 0 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -

UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

0 .8 2 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SILICA DIMETHYL SILYLATE (UNII: EU2PSP0 G0 W)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

Coswell Spa

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

GLYCERIN (UNII: PDC6 A3C0 OX)

CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79 A1)

TRIBASIC CALCIUM PHO SPHATE (UNII: 9 1D9 GV0 Z28 )

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

Product Characteristics

Color

blue (CI 420 9 0 )

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 78 1-0 0 1-0 1

75 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /14/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 6 /14/20 16

Labeler -

Coswell Spa (429512304)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Inco s Co smeceutica Industriale Srl

4349 330 32

ma nufa c ture (70 78 1-0 0 1)

Revised: 1/2020

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