FDA.reportPublic FDA data

Theraworx Nerve Relief Foam

Manufacturer
AVADIM HOLDINGS, INC.
Effective date
2023-04-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:21:01

Label at a glance#

ProductTheraworx Nerve Relief Foam
Active ingredientONION, HYPERICUM PERFORATUM WHOLE, SANGUINARIA CANADENSIS ROOT
Label structure6 sections

Indications and uses

relieves nerve discomfort  soothes aggravated nerves  targets nerve receptors

Dosage and administration

shake well  apply 2 pumps to each affected area rub in briskly until absorbed  repeat and allow to air dry  use as needed

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allium cepa 10X 0.05% HPUS

Hypericum perforatum 10X 0.05% HPUS

Sanguinaria canadensis 8X 0.05% HPUS

The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

For the temporary relief of nerve pain

Uses

INDICATIONS & USAGE SECTION

  • relieves nerve discomfort 
  • soothes aggravated nerves 
  • targets nerve receptors

Warnings

WARNINGS SECTION

For external use only. If eye contact occurs, rinse thoroughly with water.

When using this product

OTC - WHEN USING SECTION

  • avoid eye contact
  • store between 32ºF and 120ºF
  • ues only as directed 
  • not for ingestion

Stop use and ask a doctor if 

OTC - STOP USE SECTION

unintended effects occurs.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of chidlren.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well 
  • apply 2 pumps to each affected area
  • rub in briskly until absorbed 
  • repeat and allow to air dry 
  • use as needed

Inactive Ingredients (Alphabetical)

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Aqua (Water), Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Croton Lechieri Resin Extract, Decyl Glucoside, Diazolidinyl Urea, Glycerin, Leuconostoc/ Radish Root Ferment Filtrate, Methylparaben, PEG / PPG - 4/12 Dimethicone, Propylene Glycol, Propylparaben, Tetrasodium EDTA, Tocopheryl Acetate, Yeast Extract

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-020-00Theraworx Nerve Relief Foam210 mL in 1 BOTTLEAEROSOL, FOAM2103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-020THERAWORX NERVE RELIEF FOAM (ONION, HYPERICUM PERFORATUM WHOLE, SANGUINARIA CANADENSIS ROOT) AEROSOL, FOAM [AVADIM HOLDINGS, INC.]3Current NDC, Legacy NDC, 1 package rows20230426_9ed7d5fc-ad84-499b-a774-feedf21ca8d4.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61594-02061594-020-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SILVER3M4G523W1GIACT
CROTON LECHLERI RESINGGG6W25C63IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
METHYLPARABENA2I8C7HI9TIACT
PEG/PPG-4/12 DIMETHICONEJAN3585W85IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
ONION492225Q21HACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB

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
Theraworx Nerve Relief FoamONION, HYPERICUM PERFORATUM WHOLE, SANGUINARIA CANADENSIS ROOTAVADIM HOLDINGS, INC.9ed7d5fc-ad84-499b-a774-feedf21ca8d42023-04-25WarningsExact identifier
ndc (package): 61594-020-00
ndc (product): 61594-020
ndc11 (package): 61594002000
spl id: fa2348f9-1227-b787-e053-6394a90a4863
spl set id: 9ed7d5fc-ad84-499b-a774-feedf21ca8d4

Reported adverse events (FAERS/openFDA)#

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