NAVI MAXON Sirin Doctor by EQ Maxon Corp.

NAVI MAXON Sirin Doctor by

Drug Labeling and Warnings

NAVI MAXON Sirin Doctor by is a Otc medication manufactured, distributed, or labeled by EQ Maxon Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NAVI MAXON SIRIN DOCTOR- calcium phosphate tribasic colloidal silicon dioxide paste 
EQMAXON 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.

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ACTIVE INGREDIENT

Active Ingredients: Calcium Phosphate Tribasic 19%, Colloidal Silicon Dioxide 2.5%

PURPOSE

Purpose: Anticavity

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years old

INDICATIONS & USAGE

- Supervise children as necessary until being capable of using without supervision

- Instruct children under 6 years old in good brushing and rinsing habits

WARNINGS

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

Inactive Ingredients: Xylitol, Erythritol, Chitosan, D-Sorbitol Solution, L-Menthol, Lactic Acid

DOSAGE & ADMINISTRATION

- Brush teeth twice daily or after each meal as directed by a dentist or doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAVI MAXON SIRIN DOCTOR 
calcium phosphate tribasic colloidal silicon dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55526-0004
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	22.8 g  in 120 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	3 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55526-0004-1	120 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2013	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	04/01/2013	11/01/2019

Labeler - EQMAXON Corp. (557821534)

Registrant - EQMAXON Corp. (557821534)

Establishment
Name	Address	ID/FEI	Business Operations
EQMAXON Corp.		557821534	manufacture(55526-0004)

Revised: 12/2019

Document Id: 0f90eb38-194d-4266-840a-1fdcc0127814

34390-5

Set id: 1d955366-a435-4dca-828d-8af3cdcf3201

Version: 3

Effective Time: 20191226