Label: GUM THERAPY- calendula officinalis, kali phosphoricum, natrum muriaticum, arnica montana, agave americana, cistus canadensis, kreosotum, myrrha, calcarea fluorica, aconitum napellus, bismuthum subnitricum, sepia, hepar sulphuris calcareum, mercurius vivus liquid
- NDC Code(s): 43742-1509-1
- Packager: Deseret Biologicals
- 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 July 19, 2023
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ACTIVE INGREDIENTS:
Calendula Officinalis 1X, 6X, 12X, 30X, Kali Phosphoricum 3X, Natrum Muriaticum 3X, Arnica Montana 3X, 6X, 12X, 30X, Agave Americana 6X, Cistus Canadensis 6X, Kreosotum 6X, Myrrha 6X, Calcarea Fluorica 8X, Aconitum Napellus 12X, Bismuthum Subnitricum 12X, Sepia 12X, Hepar Sulphuris Calcareum 12X, 18X, 30X, Mercurius Vivus 12X, 18X, 30X.
- HOMEOPATHIC INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- HOMEOPATHIC INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
GUM THERAPY
calendula officinalis, kali phosphoricum, natrum muriaticum, arnica montana, agave americana, cistus canadensis, kreosotum, myrrha, calcarea fluorica, aconitum napellus, bismuthum subnitricum, sepia, hepar sulphuris calcareum, mercurius vivus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1509 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 1 mL DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE 3 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 3 [hp_X] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_X] in 1 mL AGAVE AMERICANA LEAF (UNII: 8511ZMP5QK) (AGAVE AMERICANA LEAF - UNII:8511ZMP5QK) AGAVE AMERICANA LEAF 6 [hp_X] in 1 mL HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3) HELIANTHEMUM CANADENSE 6 [hp_X] in 1 mL WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE 6 [hp_X] in 1 mL MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH 8 [hp_X] in 1 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 12 [hp_X] in 1 mL ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 12 [hp_X] in 1 mL BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE 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 CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 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:43742-1509-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/20/2019 04/25/2027 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/20/2019 04/25/2027 Labeler - Deseret Biologicals (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1509) , api manufacture(43742-1509) , label(43742-1509) , pack(43742-1509)