Label: TEETH AND GUM FORMULA- calc carb, calc fluor, calc phos, chamomilla, coccinella, coffea cruda, hekla, hypericum, kreosotum, ledum, mag phos, merc viv liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0181-2 - Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 12, 2018
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients: Calc carb, Calc fluor, Calc phos, Chamomilla, Coccinella, Coffea cruda, Hekla, Hypericum, Kreosotum, Ledum, Mag phos, Merc viv.
Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TEETH AND GUM FORMULA
calc carb, calc fluor, calc phos, chamomilla, coccinella, coffea cruda, hekla, hypericum, kreosotum, ledum, mag phos, merc viv liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0181 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] in 59 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 10 [hp_X] in 59 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 10 [hp_X] in 59 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X] in 59 mL COCCINELLA SEPTEMPUNCTATA (UNII: 9894B4Y2EN) (COCCINELLA SEPTEMPUNCTATA - UNII:9894B4Y2EN) COCCINELLA SEPTEMPUNCTATA 10 [hp_X] in 59 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 10 [hp_X] in 59 mL HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA 10 [hp_X] in 59 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 59 mL WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE 10 [hp_X] in 59 mL LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 10 [hp_X] in 59 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 59 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARYA OVATA BARK (UNII: X765CF609L) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR) REBAUDIOSIDE A (UNII: B3FUD0528F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0181-2 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/12/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/12/2018 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-0181)
