NAVI MATE SILVER- sodium monofluorophosphate silicon dioxide paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4), SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

EQ Maxon Corp.

INN (International Name):

SILICON DIOXIDE

Composition:

SILICON DIOXIDE 21.36 g in 120 g

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Anticavity - Supervise children as necessary until being capable of using without supervision - Instruct children under 6 years old in good brushing and rinsing habits

Authorization status:

OTC monograph final

Summary of Product characteristics

NAVI MATE SILVER- SODIUM MONOFLUOROPHOSPHATE SILICON DIOXIDE PASTE
EQ MAXON CORP.
_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._
----------
Active Ingredients: Silicon Dioxide 17.8%, Sodium Monofluorophosphate
0.46%
Purpose: Anticavity
Keep out of reach of children under 6 years old
- Supervise children as necessary until being capable of using without
supervision
- Instruct children under 6 years old in good brushing and rinsing
habits
If more than used for brushing is accidentally swallowed, get medical
help or contact a Poison Control
Center right away
Inactive Ingredients: Xylitol, Erythritol, Chitosan, D-Sorbitol
Solution, L-Menthol, Green Tea Extract,
Silver Foil, Peppermint Oil
- Brush teeth twice daily or after each meal as directed by a dentist
or doctor
EQ Maxon Corp.
NAVI MATE SILVER
sodium monofluorophosphate silicon dioxide paste
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:55526 -0 0 0 3
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRE NG TH
STRE NG TH
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) (COLLOIDAL SILICON DIOXIDE -
UNII:ETJ7Z6 XBU4)
SILICON DIOXIDE
21.36 g
in 120 g
SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -
UNII:Q8 0 VPU40 8 O)
FLUORIDE ION
0 .552 g
in 120 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
XYLITO L (UNII: VCQ0 0 6 KQ1E)
ERYTHRITO L (UNII: RA9 6 B9 54X6 )
SO RBITO L (UNII: 50 6 T6 0 A25R)
CHITO SAN O LIGO SACCHARIDE (UNII: 23R9 3M6 Y6 4)
LEVO MENTHO L (UNII: BZ1R15MTK7)
GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )
PEPPERMINT O IL (UNII: AV0 9 2KU4JH)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:55526 -0 0 0 3-1
120 g in 1 TUBE
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 4/0 1/