NAVI Black and C-Clinic by EQ Maxon Corp.

NAVI Black and C-Clinic by

Drug Labeling and Warnings

NAVI Black and C-Clinic by is a Otc medication manufactured, distributed, or labeled by EQ Maxon Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NAVI BLACK AND C-CLINIC- calcium carbonate aminocaproic acid aluminum chlorohydroxy allantoinate dibasic calcium phosphate 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 Carbonate 40%, Aminocaproic Acid 0.1%, Aluminum Chlorohydroxy Allantoinate 0.1%, Dibasic Calcium Phosphate 0.8%

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, D-Sorbitol Solution, L-Menthol, Peppermint Oil, Medicinal Carbon

DOSAGE & ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAVI BLACK AND C-CLINIC 
calcium carbonate aminocaproic acid aluminum chlorohydroxy allantoinate dibasic calcium phosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55526-0005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	48 g  in 120 g
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)	AMINOCAPROIC ACID	0.12 g  in 120 g
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J)	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	0.12 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
ERYTHRITOL (UNII: RA96B954X6)
SORBITOL (UNII: 506T60A25R)
LEVOMENTHOL (UNII: BZ1R15MTK7)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55526-0005-1	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(55526-0005)

Revised: 12/2019

Document Id: fdda0bb7-0b08-430b-8296-82798661c361

34390-5

Set id: 5da20eb3-0817-49e7-be6e-99b224b98b03

Version: 3

Effective Time: 20191226