Label: ORAL HEALTH (borax, bryonia (alba), echinacea purpurea, juglans cinerea, kali muriaticum, magnesia muriatica, muriaticum acidum, discus intervertebralis suis, oral mucosa- suis, antimonium crudum, arsenicum album, bismuthum subnitricum, chamomilla, cinchona officinalis, nux moschata, sambucus nigra, sepia, mercurius solubilis, calcarea phosphorica, ignatia amara, oxygenium, candida albicans, staphylococcus aureus, streptococcus mutans liquid
- NDC Code(s): 43742-1592-1
- Packager: Deseret Biologicals, 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 March 5, 2024
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ACTIVE INGREDIENTS:
Borax 6X, Bryonia (Alba) 6X, Echinacea Purpurea 6X, Juglans Cinerea 6X, Kali Muriaticum 6X, Magnesia Muriatica 6X, Muriaticum Acidum 6X, Discus Intervertebralis Suis 8X, 12X, 18X, 24X, 30X, Oral Mucosa (Suis) 8X, 12X, 18X, 24X, 30X, Antimonium Crudum 12X, Arsenicum Album 12X, Bismuthum Subnitricum 12X, Chamomilla 12X, Cinchona Officinalis 12X, Nux Moschata 12X, Sambucus Nigra 12X, Sepia 12X, Mercurius Solubilis 12X, 18X, 24X, 30X, Calcarea Phosphorica 12X, 18X, 30X, Ignatia Amara 12X, 30X, Oxygenium 16X, Candida Albicans 16X, 18X, 24X, 30X, Staphylococcus Aureus 12C, 18C, 24C, 30C, Streptococcus Mutans 12C, 18C, 24C, 30C.
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HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to oral health, such as cavitation, delayed dentition, dry mouth, painful eating, eruptions on tongue and inner cheeks and tooth sensitivity.**
**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to oral health, such as cavitation, delayed dentition, dry mouth, painful eating, eruptions on tongue and inner cheeks and tooth sensitivity.**
**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ORAL HEALTH
borax, bryonia (alba), echinacea purpurea, juglans cinerea, kali muriaticum, magnesia muriatica, muriaticum acidum, discus intervertebralis suis, oral mucosa (suis), antimonium crudum, arsenicum album, bismuthum subnitricum, chamomilla, cinchona officinalis, nux moschata, sambucus nigra, sepia, mercurius solubilis, calcarea phosphorica, ignatia amara, oxygenium, candida albicans, staphylococcus aureus, streptococcus mutans liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1592 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 6 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA WHOLE 6 [hp_X] in 1 mL JUGLANS CINEREA BRANCH BARK/ROOT BARK (UNII: 48FZ1BHO18) (JUGLANS CINEREA BRANCH BARK/ROOT BARK - UNII:48FZ1BHO18) JUGLANS CINEREA BRANCH BARK/ROOT BARK 6 [hp_X] in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION 6 [hp_X] in 1 mL MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 6 [hp_X] in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB) HYDROCHLORIC ACID 6 [hp_X] in 1 mL SUS SCROFA INTERVERTEBRAL DISC (UNII: OJ17O2WTSM) (SUS SCROFA INTERVERTEBRAL DISC - UNII:OJ17O2WTSM) SUS SCROFA INTERVERTEBRAL DISC 8 [hp_X] in 1 mL SUS SCROFA ORAL MUCOSA (UNII: DUP6W562BM) (SUS SCROFA ORAL MUCOSA - UNII:DUP6W562BM) SUS SCROFA ORAL MUCOSA 8 [hp_X] in 1 mL ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE 12 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE 12 [hp_X] in 1 mL MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 12 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 12 [hp_X] in 1 mL NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 12 [hp_X] in 1 mL SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 12 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 12 [hp_X] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 12 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 12 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 12 [hp_X] in 1 mL OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 16 [hp_X] in 1 mL CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 16 [hp_X] in 1 mL STAPHYLOCOCCUS AUREUS (UNII: O478WX4004) (STAPHYLOCOCCUS AUREUS - UNII:O478WX4004) STAPHYLOCOCCUS AUREUS 12 [hp_C] in 1 mL STREPTOCOCCUS MUTANS (UNII: 5C7J33MJJ1) (STREPTOCOCCUS MUTANS - UNII:5C7J33MJJ1) STREPTOCOCCUS MUTANS 12 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43742-1592-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 02/19/2020 09/19/2028 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/19/2020 09/19/2028 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1592) , api manufacture(43742-1592) , label(43742-1592) , pack(43742-1592)
