Label: NAVI BLACK AND C-CLINIC- calcium carbonate aminocaproic acid aluminum chlorohydroxy allantoinate dibasic calcium phosphate paste
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- NDC Code(s): 55526-0005-1
- Packager: EQ Maxon Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 2, 2013
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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%
Close - PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- 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
Close - WARNINGS
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away
Close - INACTIVE INGREDIENT
Inactive Ingredients: Xylitol, Erythritol, D-Sorbitol Solution, L-Menthol, Peppermint Oil, Medicinal Carbon
Close - DOSAGE & ADMINISTRATION
- INGREDIENTS AND APPEARANCE
NAVI BLACK AND C-CLINIC
calcium carbonate aminocaproic acid aluminum chlorohydroxy allantoinate dibasic calcium phosphate pasteProduct 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 04/01/2013 Labeler - EQ Maxon Corp. (557821534) CloseEstablishment Name Address ID/FEI Business Operations EQ Maxon Corp. 557821534 manufacture(55526-0005)