FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
Peaceful Mountain, Inc. | Apotheca Company
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:38:34

Label at a glance#

ProductBack, Neck and Sciatic Rescue
Active ingredientPHYTOLACCA AMERICANA ROOT, PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE, HYPERICUM PERFORATUM WHOLE, CITRULLUS COLOCYNTHIS FRUIT PULP, GELSEMIUM SEMPERVIRENS ROOT, GUAIACUM OFFICINALE RESIN, RHODODENDRON TOMENTOSUM LEAFY TWIG, CONIUM MACULATUM FLOWERING TOP
Label structure9 sections

Dosage and administration

Apply at least 3 times daily over the affected area. Children under 12 years of age: Consult a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

0.13% of Colocynthis 6X, Conium Maculatum 30X, Gelsemium Sempervirens 6X, Gnaphalium Polycephalum 3X, Guaiacum 6X, Hypericum Perforatum 3X, Ledum Palustre 6X, Phytolacca Decandra 4X.

PURPOSE:

OTC - PURPOSE SECTION

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

For external use only.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product • Do not get into eyes.

Stop use and ask a doctor if • Conditions worsens · Symptoms last more than 7 days.

Do not use if safety seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply at least 3 times daily over the affected area.

Children under 12 years of age: Consult a doctor.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water/Arnica (Arnica montana) Flower/Comfrey (Symphytum officinale) Leaf/Kava (Piper methysticum) Root/Poke (Phytolacca americana) Root/St. John's Wort (Hypericum perforatum) Leaf, flower, stem/White Willow (Salix alba) Bark/Yarrow (Achillea millefolium) Flower/Lavender (Lavandula angustifolia) Buds/Ascorbic Acid Extract, Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherols (soy), Disodium EDTA, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back, neck and

sciatic rescue

peaceful mountain
THE HEIGHT OF HEALTH

homeopathic gel
paraben-free

Net wt. 2 oz. (57 g)

Back, Neck and Sciatic RescueBack, Neck and Sciatic Rescue

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130818692009504GTIN-13: 0818692009504
EAN-13: 0818692009504
GTIN-12: 818692009504
UPC-A: 818692009504
GTIN storage (14 digits): 00818692009504		PMTN0043 Back, Neck and Sciatic Rescue 10-28-24.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0076-12024-06-12C16284748780-1f386c649-ab9e-0266-e053-dadaa90a7c1aDRUG FACTS:
43846-0076-12023-01-30C16284748780-1f386c649-ab9e-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43846-0076-1Back, Neck and Sciatic Rescue57 g in 1 TUBEGEL574

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43846-007643846-0076-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE36XQ854NWWACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
SODIUM HYDROXIDE55X04QC32IIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POLYETHYLENE GLYCOL 700762678AC5RIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
EDETATE DISODIUM7FLD91C86KIACT
OREGANO0E5AT8T16UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
COMFREY LEAFDG4F8T839XIACT
MACROPIPER METHYSTICUM ROOTBOW48C81XPIACT
HYPERICUM PERFORATUM FLOWERA6V4CUE7PVIACT
SALIX ALBA BARK205MXS71H7IACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
ASCORBIC ACIDPQ6CK8PD0RIACT

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
Back, Neck and Sciatic RescuePHYTOLACCA DECANDRA, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, COLOCYNTHIS, GELSEMIUM SEMPERVIRENS, GUAIACUM, LEDUM PALUSTRE, CONIUM MACULATUMPeaceful Mountain, Inc.dc2033a7-a322-4733-8bfe-5a36fe1fa8072026-05-12WarningsExact identifier
ndc (package): 43846-0076-1
ndc (product): 43846-0076
ndc11 (package): 43846007601
spl id: 2c65e327-2421-4740-b4d5-737e60c903ac
spl set id: dc2033a7-a322-4733-8bfe-5a36fe1fa807

Reported adverse events (FAERS/openFDA)#

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