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

Spinalmax by

Drug Labeling and Warnings

Spinalmax by is a Homeopathic medication manufactured, distributed, or labeled by Deseret Biologicals, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Berberis Vulgaris 4X, Cimicifuga Racemosa 4X, Cinchona Officinalis 4X, Colocynthis 4X, Ledum Palustre 4X, Ranunculus Bulbosus 4X, Aesculus Hippocastanum 6X, Cuprum Aceticum 6X, Nadidum 6X, Natrum Oxalaceticum 6X, Nicotinamidum 6X, Pyridoxinum Hydrochloricum 6X, Riboflavinum 6X, Thiaminum Hydrochloricum 6X, alpha-Lipoicum Acidum 8X, Ammonium Muriaticum 8X, Cartilago Suis 8X, Discus Intervertebralis (Suis) 8X, Picricum Acidum 8X, Silicea 8X, Argentum Metallicum 10X, Calcarea Phosphorica 10X, Funiculus Umbilicalis Suis 10X, Glandula Suprarenalis Suis 10X, Gnaphalium Polycephalum 10X, Medulla Ossis Suis 10X, Mercurius Praecipitatus Ruber 10X, Pantothenic Acid 10X, Sulphur 28X, Bacillus 7 30C, Gaertner Bacillus (Bach) 30C, Proteus (Morgani) 30C, Proteus (Vulgaris) 30C.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to spine issues including spasm, pain, anxiety, nervousness and the inability to hold chiropractic spinal adjustments.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

Keep out of reach of children. In case of overdose, contact physician or a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or a Poison Control Center right away.

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to spine issues including spasm, pain, anxiety, nervousness and the inability to hold chiropractic spinal adjustments.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC: 43742-1326-1

HOMEOPATHIC

SPINALMAX

1 FL OZ (30 ml)

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 liquid

Product 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
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE 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
THIOCTIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y)	THIOCTIC 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 (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM	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)