Label: DENTAL PAIN (aceticum acidum, calendula officinalis, zingiber officinale, bryonia- alba, coffea tosta, ledum palustre, phosphorus, plantago major, spigelia anthelmia, arnica montana, chamomilla, hepar sulphuris calcareum, hypericum perforatum, aconitum napellus, antimonium crudum, mezereum, sepia, staphysagria, magnesia phosphorica liquid
- NDC Code(s): 43742-1523-1
- 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 October 23, 2024
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ACTIVE INGREDIENTS:
Aceticum Acidum 3X, Aconitum Napellus 12X, Antimonium Crudum 12X, Arnica Montana 6X, 12X, 18X, 30X, Bryonia (Alba) 6X, Calendula Officinalis 3X, Chamomilla 6X, 12X, 18X, 30X, Coffea Tosta 6X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 8X, 12X, 18X, 30X, Ledum Palustre 6X, Magnesia Phosphorica 12X, 30X, Mezereum 12X, Phosphorus 6X, Plantago Major 6X, Sepia 12X, Spigelia Anthelmia 6X, Staphysagria 12X, 18X, 24X, 30X, Zingiber Officinale 3X.
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PURPOSE:
Aceticum Acidum – Dental Pain, Aconitum Napellus – Sensitive Teeth, Antimonium Crudum - Salivation, Arnica Montana – Cramping in the Jaw, Bryonia (Alba) – Sensitivity to Temperature, Calendula Officinalis – Sensitivity to Brushing, Chamomilla – Sensitivity to Brushing, Coffea Tosta – Dental Pain, Hepar Sulphuris Calcareum – Dental Pain, Hypericum Perforatum – Sensitive Teeth, Ledum Palustre - Salivation, Magnesia Phosphorica – Cramping in the Jaw, Mezereum – Sensitivity to Temperature, Phosphorus – Sensitivity to Brushing, Plantago Major - Salivation, Sepia – Dental Pain, Spigelia Anthelmia – Sensitive Teeth, Staphysagria – Generalized Dental Discomfort, Zingiber Officinale – Sensitive Teeth
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USES:
• For the temporary relief of symptoms including:
• sensitivity to temperature • dental pain • sensitive teeth • cramping in jaw
• salivation • generalized dental discomfort • sensitivity to brushing
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
DENTAL PAIN
aceticum acidum, calendula officinalis, zingiber officinale, bryonia (alba), coffea tosta, ledum palustre, phosphorus, plantago major, spigelia anthelmia, arnica montana, chamomilla, hepar sulphuris calcareum, hypericum perforatum, aconitum napellus, antimonium crudum, mezereum, sepia, staphysagria, magnesia phosphorica liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1523 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID 3 [hp_X] in 1 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1 mL GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 3 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED 6 [hp_X] in 1 mL RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [hp_X] in 1 mL PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE 6 [hp_X] in 1 mL SPIGELIA ANTHELMIA WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE 6 [hp_X] in 1 mL ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [hp_X] in 1 mL HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 8 [hp_X] in 1 mL ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 12 [hp_X] in 1 mL ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE 12 [hp_X] in 1 mL DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK 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 DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 12 [hp_X] in 1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X] 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:43742-1523-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/21/2019 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1523) , api manufacture(43742-1523) , label(43742-1523) , pack(43742-1523)
