FDA.reportPublic FDA data

Sciatica-Back Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:56

Label at a glance#

ProductSciatica-Back Care
Active ingredientACONITUM NAPELLUS, AMMONIUM BENZOATE, ARSENIC TRIOXIDE, BENZOIC ACID, BRYONIA ALBA ROOT, CAUSTICUM, CINCHONA OFFICINALIS BARK, COLCHICUM AUTUMNALE BULB, PSEUDOGNAPHALIUM OBTUSIFOLIUM, IRIS VERSICOLOR ROOT, POTASSIUM IODIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, LITHIUM CARBONATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SAMBUCUS NIGRA FLOWERING TOP, STRYCHNINE, HYPERICUM PERFORATUM, URTICA URENS
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as inflammatoin, sharp or throbbing pain, numbness and backache.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Hypericum perforatum 11x, Urtica urens 11x, Aconitum napellus 20x, Ammonium benzoicum 20x, Arsenicum album 20x, Benzoicum acidum 20x, Bryonia 20x, Causticum 20x, Cinchona officinalis 20x, Colchicum autumnale 20x, Gnaphalium polycephalum 20x, Iris versicolor 20x, Kali iodatum 20x, Ledum palustre 20x, Lithium carbonicum 20x, Nux vomica 20x, Phytolacca decandra 20x, Rhus toxicodendron 20x, Ruta graveolens 20x, Sambucus nigra 20x, Strychninum 20x.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4803-1Sciatica-Back Care30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4803SCIATICA-BACK CARE (ACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA UR) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201208_99ea75a9-3250-281b-e053-2a95a90aed45.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-480355714-4803-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
AMMONIUM BENZOATEAC80WD7GPFACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BENZOIC ACID8SKN0B0MIMACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CAUSTICUMDD5FO1WKFUACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
PSEUDOGNAPHALIUM OBTUSIFOLIUM36XQ854NWWACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
LITHIUM CARBONATE2BMD2GNA4VACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
STRYCHNINEH9Y79VD43JACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
URTICA URENSIHN2NQ5OF9ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sciatica-Back CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.99ea75a9-3250-281b-e053-2a95a90aed452020-12-07WarningsExact identifier
ndc (package): 55714-4803-1
ndc (product): 55714-4803
ndc11 (package): 55714480301
spl id: b5e3c3ce-a444-ea15-e053-2995a90af813
spl set id: 99ea75a9-3250-281b-e053-2a95a90aed45

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.