Label: ORAL HEALTH (antimonium crudum, arsenicum album, bismuthum subnitricum, borax, bryonia (alba), calcarea phosphorica, candida albicans, chamomilla, cinchona officinalis, discus intervertebralis suis, streptococcus dysgalactiae dna, streptococcus mutans dna, streptococcus pneumoniae dna, echinacea purpurea, ignatia amara, juglans cinerea, kali muriaticum, magnesia muriatica, mercurius solubilis, muriaticum acidum, nux moschata, oral mucosa- suis, oxygenium, sambucus nigra, sepia, staphylococcus aureus, liquid
- NDC Code(s): 43742-2122-1
- 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 April 1, 2024
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ACTIVE INGREDIENTS:
Antimonium Crudum 12X, Arsenicum Album 12X, Bismuthum Subnitricum 12X, Borax 6X, Bryonia (Alba) 6X, Calcarea Phosphorica 12X, 18X, 30X, Candida Albicans 16X, 18X, 24X, 30X, Chamomilla 12X, Cinchona Officinalis 12X, Discus Intervertebralis Suis 8X, 12X, 18X, 24X, 30X, DNA 12C, 18C, 24C, 30C, Echinacea Purpurea 6X, Ignatia Amara 12X, 30X, Juglans Cinerea 6X, Kali Muriaticum 6X, Magnesia Muriatica 6X, Mercurius Solubilis 12X, 18X, 24X, 30X, Muriaticum Acidum 6X, Nux Moschata 12X, Oral Mucosa (Suis) 8X, 12X, 18X, 24X, 30X, Oxygenium 16X, Sambucus Nigra 12X, Sepia 12X, Staphylococcus Aureus 12C, 18C, 24C, 30C, Streptococcus Mutans 12C, 18C, 24C, 30C.
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PURPOSE:
Antimonium Crudum – Mouth Support, Arsenicum Album – Dental Support, Bismuthum Subnitricum – Pain in Ears, Borax – Dry Mouth, Bryonia (Alba) – Eruption on Tongue, Calcarea Phosphorica – Dental Issues, Candida Albicans – Eruption on Cheeks, Chamomilla – Teeth Sensitivity, Cinchona Officinalis – Mouth Support, Discus Intervertebralis Suis – Dry Mouth, DNA – Mouth Support, Echinacea Purpurea – Mouth Support, Ignatia Amara – Teeth Sensitivity, Juglans Cinerea – Pain in Ears, Kali Muriaticum – Eruption on Tongue, Magnesia Muriatica – Dental Support, Mercurius Solubilis – Teeth Sensitivity, Muriaticum Acidum – Dry Mouth, Nux Moschata – Dry Mouth, Oral Mucosa (Suis) – Mouth Support, Oxygenium – Eruption on Tongue, Sambucus Nigra – Dry Mouth, Sepia – Teeth Sensitivity, Staphylococcus Aureus – Mouth Support, Streptococcus Mutans – Mouth Support
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USES:
• For the temporary relief of symptoms including:
• mouth support • teeth sensitivity • dental issues
• dental support • pain in ears • eruption on tongue
• eruption on cheeks • dry mouth
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:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ORAL HEALTH
antimonium crudum, arsenicum album, bismuthum subnitricum, borax, bryonia (alba), calcarea phosphorica, candida albicans, chamomilla, cinchona officinalis, discus intervertebralis suis, streptococcus dysgalactiae dna, streptococcus mutans dna, streptococcus pneumoniae dna, echinacea purpurea, ignatia amara, juglans cinerea, kali muriaticum, magnesia muriatica, mercurius solubilis, muriaticum acidum, nux moschata, oral mucosa (suis), oxygenium, sambucus nigra, sepia, staphylococcus aureus, liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-2122 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 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 TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 12 [hp_X] in 1 mL CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 16 [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 SUS SCROFA INTERVERTEBRAL DISC (UNII: OJ17O2WTSM) (SUS SCROFA INTERVERTEBRAL DISC - UNII:OJ17O2WTSM) SUS SCROFA INTERVERTEBRAL DISC 8 [hp_X] in 1 mL HERRING SPERM DNA (UNII: 51FI676N6F) (HERRING SPERM DNA - UNII:51FI676N6F) HERRING SPERM DNA 12 [hp_C] in 1 mL ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA WHOLE 6 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 12 [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 MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 12 [hp_X] in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB) HYDROCHLORIC ACID 6 [hp_X] in 1 mL NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 12 [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 OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 16 [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 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:43742-2122-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/01/2024 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-2122) , api manufacture(43742-2122) , label(43742-2122) , pack(43742-2122)
