Label: SPINALMAX (berberis vulgaris, cimicifuga racemosa, cinchona officinalis, colocynthis, ledum palustre, ranunculus bulbosus, aesculus hippocastanum, cuprum aceticum, nadidum, natrum oxalaceticum, nicotinamidum, pyridoxinum hydrochloricum, riboflavinum, thiaminum hydrochloricum, alpha-lipoicum acidum, ammonium muriaticum, cartilago suis, discus intervertebralis- suis, picricum acidum, silicea, argentum metallicum, calcarea phosphorica, funiculus umbilicalis suis, glandula suprarenalis suis, gnaphalium polycephalum liquid
- NDC Code(s): 43742-1326-1
- 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 September 21, 2023
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ACTIVE INGREDIENTS:
Aesculus Hippocastanum 6X, Alpha-Lipoicum Acidum 8X, Ammonium Muriaticum 8X, Argentum Metallicum 10X, Bacillus 7 30C, Berberis Vulgaris 4X, Calcarea Phosphorica 10X, Cartilago Suis 8X, Cimicifuga Racemosa 4X, Cinchona Officinalis 4X, Colocynthis 4X, Cuprum Aceticum 6X, Discus Intervertebralis Suis 8X, Funiculus Umbilicalis Suis 10X, Gaertner Bacillus 30C, Glandula Suprarenalis Suis 10X, Gnaphalium Polycephalum 10X, Ledum Palustre 4X, Medulla Ossis Suis 10X, Mercurius Praecipitatus Ruber 10X, Nadidum 6X, Natrum Oxalaceticum 6X, Nicotinamidum 6X, Pantothenic Acid 10X, Picricum Acidum 8X, Proteus (Morgani, Vulgaris) 30C, Pyridoxinum Hydrochloricum 6X, Ranunculus Bulbosus 4X, Riboflavinum 6X, Silicea 8X, Sulphur 28X,Thiaminum Hydrochloricum 6X.
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PURPOSE:
Aesculus Hippocastanum – Back Discomfort, Alpha-Lipoicum Acidum – Back Spasms, Ammonium Muriaticum – Back Pain, Argentum Metallicum - Anxiety, Bacillus 7 – Back Pain, Berberis Vulgaris – Back Discomfort, Calcarea Phosphorica – Back Spasms, Cartilago Suis - Anxiety, Cimicifuga Racemosa – Back Discomfort, Cinchona Officinalis – Back Spasms, Colocynthis – Back Pain, Cuprum Aceticum – Back Spasms, Discus Intervertebralis Suis – Back Pain, Funiculus Umbilicalis Suis – Back Discomfort, Gaertner Bacillus 3 - Anxiety, Glandula Suprarenalis Suis - Nervousness, Gnaphalium Polycephalum – Back Pain, Ledum Palustre - Nervousness, Medulla Ossis Suis - Nervousness, Mercurius Praecipitatus Ruber - Anxiety, Nadidum – Back Discomfort, Natrum Oxalaceticum – Back Discomfort, Nicotinamidum – Back Spasms, Pantothenic Acid – Nervousness, Picricum Acidum – Back Discomfort, Proteus (Morgani, Vulgaris) – Back Pain, Pyridoxinum Hydrochloricum - Anxiety, Ranunculus Bulbosus – Back Discomfort, Riboflavinum – Back Spasms, Silicea – Back Pain, Sulphur – Anxiety, Thiaminum Hydrochloricum – Back Pain.
- INDICATION:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
SPINALMAX
berberis vulgaris, cimicifuga racemosa, cinchona officinalis, colocynthis, ledum palustre, ranunculus bulbosus, aesculus hippocastanum, cuprum aceticum, nadidum, natrum oxalaceticum, nicotinamidum, pyridoxinum hydrochloricum, riboflavinum, thiaminum hydrochloricum, alpha-lipoicum acidum, ammonium muriaticum, cartilago suis, discus intervertebralis (suis), picricum acidum, silicea, argentum metallicum, calcarea phosphorica, funiculus umbilicalis suis, glandula suprarenalis suis, gnaphalium polycephalum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1326 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 4 [hp_X] in 1 mL BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 4 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 4 [hp_X] in 1 mL CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 4 [hp_X] in 1 mL RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG 4 [hp_X] in 1 mL RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS 4 [hp_X] in 1 mL HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 6 [hp_X] in 1 mL CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ACETATE 6 [hp_X] in 1 mL NADIDE (UNII: 0U46U6E8UK) (NADIDE - UNII:0U46U6E8UK) NADIDE 6 [hp_X] in 1 mL SODIUM DIETHYL OXALACETATE (UNII: 6CA025Y4FG) (DIETHYL OXALACETATE - UNII:15S56468G7) SODIUM DIETHYL OXALACETATE 6 [hp_X] in 1 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 6 [hp_X] in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 6 [hp_X] in 1 mL RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 6 [hp_X] in 1 mL THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 6 [hp_X] in 1 mL ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y) ALPHA LIPOIC ACID 8 [hp_X] in 1 mL AMMONIUM CHLORIDE (UNII: 01Q9PC255D) (AMMONIUM CATION - UNII:54S68520I4) AMMONIUM CATION 8 [hp_X] in 1 mL SUS SCROFA CARTILAGE (UNII: 73ECW5WG2F) (SUS SCROFA CARTILAGE - UNII:73ECW5WG2F) SUS SCROFA CARTILAGE 8 [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 PICRIC ACID (UNII: A49OS0F91S) (PICRIC ACID - UNII:A49OS0F91S) PICRIC ACID 8 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [hp_X] in 1 mL SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 10 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 10 [hp_X] in 1 mL SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H) SUS SCROFA UMBILICAL CORD 10 [hp_X] in 1 mL SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND 10 [hp_X] in 1 mL PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE 10 [hp_X] in 1 mL SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8) SUS SCROFA BONE MARROW 10 [hp_X] in 1 mL MERCURIC OXIDE (UNII: IY191986AO) (MERCURIC OXIDE - UNII:IY191986AO) MERCURIC OXIDE 10 [hp_X] in 1 mL PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 10 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 28 [hp_X] in 1 mL ENTEROBACTER CLOACAE (UNII: 40OMQ8YEPD) (ENTEROBACTER CLOACAE - UNII:40OMQ8YEPD) ENTEROBACTER CLOACAE 30 [hp_C] in 1 mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS - UNII:Y3V16D4PV4) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 30 [hp_C] in 1 mL PROTEUS MORGANII (UNII: 56X6LID5ZY) (PROTEUS MORGANII - UNII:56X6LID5ZY) PROTEUS MORGANII 30 [hp_C] in 1 mL PROTEUS VULGARIS (UNII: 11T9HCO30O) (PROTEUS VULGARIS - UNII:11T9HCO30O) PROTEUS VULGARIS 30 [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:43742-1326-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 05/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/17/2019 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1326) , api manufacture(43742-1326) , label(43742-1326) , pack(43742-1326)