NDC | 42352-2001-1 |
Set ID | b01d1844-f8f0-4797-a7b8-eece3c18a368 |
Category | HUMAN OTC DRUG LABEL |
Packager | Solbin Co., Ltd |
Generic Name | |
Product Class | Antifibrinolytic Agent |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Inactive ingredients: calcium carbonate, dibasic calcium phosphate hydrate, amonicaproic acid, aluminium chlorohydroxy allantoinate, glycerine, D-sorbitol, polyethylene glycol-1500, carboxymethylcellulose sodium, sodium lauryl sulfate, methylparaben, xylitol, L-menthol, peppermint oil, yellow no.5, blue no.1, angelica dahurica root extract, phellodendron bark extract, rosin, purified water
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SOLMEET DENTI DOCTOR
calcium carbonate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42352-2001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 15.85 g in 100 g DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC CALCIUM PHOSPHATE DIHYDRATE 0.6 g in 100 g AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID 0.05 g in 100 g ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA 0.05 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYLPARABEN (UNII: A2I8C7HI9T) XYLITOL (UNII: VCQ006KQ1E) LEVOMENTHOL (UNII: BZ1R15MTK7) PEPPERMINT (UNII: V95R5KMY2B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) ROSIN (UNII: 88S87KL877) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42352-2001-1 120 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/15/2010 Labeler - Solbin Co., Ltd (631099371) Registrant - Solbin Co., Ltd (631099371) Establishment Name Address ID/FEI Business Operations Solbin Co., Ltd 631099371 manufacture