FDA.reportPublic FDA data

Theraworx Relief Joint Discomfort and Inflammation

Manufacturer
AVADIM HOLDINGS, INC.
Effective date
2024-06-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:27:24

Label at a glance#

ProductTheraworx Relief Joint Discomfort and Inflammation
Active ingredientFRANKINCENSE
Label structure7 sections

Indications and uses

relives joint discomfort increases range of motion improves daily function

Dosage and administration

shake bottle well apply 2 pumps to each affected area rub in briskly until absorbed repeat allow to air dry if applicable put on compression use as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Olibanum 8x H.P.U.S. 0.05

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

Purpose

OTC - PURPOSE SECTION

Anti Inflammatory

Uses

INDICATIONS & USAGE SECTION

  • relives joint discomfort
  • increases range of motion
  • improves daily function

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 32°F and 120°F
  • use only as directed
  • not for ingestion

Stop use and ask a doctor if

OTC - STOP USE SECTION

unintended effects occur.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

  • shake bottle well
  • apply 2 pumps to each affected area
  • rub in briskly until absorbed
  • repeat
  • allow to air dry
  • if applicable put on compression
  • use as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Croton Lechleri Resin Extract, Agnus Castus Berry Extract, Calcium Carbonate, Colloidal Silver, Tocopheryl Acetate, Glycerin, Allantoin, Beta Glucan, Citrus Paradisi (Grapefruit) Fruit Extract, Lauryl Glucoside, Tetrasodium EDTA, PEG/PPG-4/12 Dimethicone, Methylparaben, propylparaben, Yucca Schidigera, Alcohol, Parfum (Fragrance)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:101ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-013-03Theraworx Relief Joint Discomfort and Inflammation101 mL in 1 BOTTLELIQUID1017
61594-013-07Theraworx Relief Joint Discomfort and Inflammation210 mL in 1 BOTTLELIQUID2107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-013THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMMATION (FRANKINCENSE) LIQUID [AVADIM HOLDINGS, INC.]7Current NDC, Legacy NDC, 2 package rows20240619_37c297f6-6b3e-495c-9f72-9327e0638cc5.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61594-01361594-013-07, 61594-013-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALOE VERA LEAFZY81Z83H0XIACT
CROTON LECHLERI RESINGGG6W25C63IACT
CALCIUM CARBONATEH0G9379FGKIACT
SILVER3M4G523W1GIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
GRAPEFRUITO82C39RR8CIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
EDETATE SODIUMMP1J8420LUIACT
PEG/PPG-4/12 DIMETHICONEJAN3585W85IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
YUCCA SCHIDIGERA WHOLE08A0YG3VICIACT
ALCOHOL3K9958V90MIACT
FRANKINCENSER9XLF1R1WMACTIB

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 Relief Joint Discomfort and InflammationFRANKINCENSEAVADIM HOLDINGS, INC.37c297f6-6b3e-495c-9f72-9327e0638cc52024-06-18WarningsExact identifier
ndc (package): 61594-013-07
ndc (package): 61594-013-03
ndc (product): 61594-013
ndc11 (package): 61594001303
ndc11 (package): 61594001307
spl id: 1b2fea8c-49c9-62eb-e063-6394a90adb5e
spl set id: 37c297f6-6b3e-495c-9f72-9327e0638cc5

Reported adverse events (FAERS/openFDA)#

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