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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB), AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206), DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J)

Available from:

EQ Maxon Corp.

INN (International Name):

CALCIUM CARBONATE

Composition:

CALCIUM CATION 48 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 BLACK AND C-CLINIC- CALCIUM CARBONATE AMINOCAPROIC ACID ALUMINUM
CHLOROHYDROXY
ALLANTOINATE DIBASIC CALCIUM PHOSPHATE 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._
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Active Ingredients: Calcium Carbonate 40%, Aminocaproic Acid 0.1%,
Aluminum Chlorohydroxy
Allantoinate 0.1%, Dibasic Calcium Phosphate 0.8%
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, D-Sorbitol Solution,
L-Menthol, Peppermint Oil, Medicinal
Carbon
- Brush teeth twice daily or after each meal as directed by a dentist
or doctor
NAVI BLACK AND C-CLINIC
calcium carbonate aminocaproic acid aluminum chlorohydroxy
allantoinate dibasic calcium phosphate paste
EQ Maxon Corp.
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:55526 -0 0 0 5
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CALCIUM CATION - UNII:2M8
3C4R6 ZB)
CALCIUM CATION
48 g
in 120 g
AMINO CAPRO IC ACID (UNII: U6 F378 720 6 ) (AMINOCAPROIC ACID -
UNII:U6 F378 720 6 )
AMINOCAPROIC ACID
0 .12 g
in 120 g
DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP) (ANHYDROUS
DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P9 2J)
ANHYDROUS DIBASIC
CALCIUM PHOSPHATE
0 .12 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)
LEVO MENTHO L (UNII: BZ1R15MTK7)
PEPPERMINT O IL (UNII: AV0 9 2KU4JH)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START