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

Image of carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

Revised: 12/2019

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

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

Version: 3

Effective Time: 20191226

EQMAXON Corp.