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

Image of carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
XYLITOL (UNII: VCQ006KQ1E)

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

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

Labeler - EQMAXON Corp. (557821534)

Registrant - EQMAXON Corp. (557821534)

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

Revised: 12/2019

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

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

Version: 3

Effective Time: 20191226

EQMAXON Corp.