FDA.reportPublic FDA data

Theraworx Joint Relief Roll On

Manufacturer
AVADIM HOLDINGS, INC.
Effective date
2023-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:11

Label at a glance#

ProductTheraworx Joint Relief Roll On
Active ingredientFRANKINCENSE
Label structure6 sections

Indications and uses

relieves joint discomfort increase range of motion improves daily function

Dosage and administration

shake well roll a thin layer to each affected area and allow to air dry if applicable put on compression repeat use as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Olibanum 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 State.

Purpose

OTC - PURPOSE SECTION

Anti Inflammatory

Uses

INDICATIONS & USAGE SECTION

  • relieves joint discomfort
  • increase 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 well
  • roll a thin layer to each affected area and allow to air dry
  • if applicable put on compression
  • repeat
  • use as needed

Inactive Ingredients (Alphabetical)

INACTIVE INGREDIENT SECTION

Allantoin, Aloe barbadensis Leaf Extract, Aloe barbadensis Leaf Juice, Aqua (Water), Benzyl Alcohol, Calcium Carbonate, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Croton Lechieri Resin Extract, Decyl Glucoside, Ethylhexylglycerin, Glycerin, PEG/PPG-4/12 Dimethicone, Parfum (Fragrance), Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopherol Acetate, Vitex Agnus- Castus Extract, Xanthan Gum, Yeast Extract, Yucca shidigera Extract

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-027-00Theraworx Joint Relief Roll On74 mL in 1 BOTTLELIQUID741
61594-027-00Theraworx Joint Relief Roll On1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-027THERAWORX JOINT RELIEF ROLL ON (FRANKINCENSE) LIQUID [AVADIM HOLDINGS, INC.]1Current NDC, 2 package rows20230901_0437aa53-e3e7-0ac6-e063-6394a90a71dd.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61594-02761594-027-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
CALCIUM CARBONATEH0G9379FGKIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SILVER3M4G523W1GIACT
CROTON LECHLERI RESINGGG6W25C63IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
PEG/PPG-4/12 DIMETHICONEJAN3585W85IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHASTE TREE FRUIT433OSF3U8AIACT
XANTHAN GUMTTV12P4NEEIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
YUCCA SCHIDIGERA WHOLE08A0YG3VICIACT
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 Joint Relief Roll OnFRANKINCENSEAVADIM HOLDINGS, INC.0437aa53-e3e7-0ac6-e063-6394a90a71dd2023-08-31WarningsExact identifier
ndc (package): 61594-027-00
ndc (product): 61594-027
ndc11 (package): 61594002700
spl id: 0437aa5f-57f9-973a-e063-6294a90a9b30
spl set id: 0437aa53-e3e7-0ac6-e063-6394a90a71dd

Reported adverse events (FAERS/openFDA)#

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