FDA.reportPublic FDA data

Theraworx Pain Relief Roll-On with Lidocaine for Diabetics

Manufacturer
AVADIM HOLDINGS, INC.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:15

Label at a glance#

ProductTheraworx Pain Relief Roll-On with Lidocaine for Diabetics
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adults and children 2 years of age and older:  shake bottle well  roll a thin layer to each affected area and allow to air dry  repeat  Wash hands after applying product  do not use more than 3 to 4 times daily  children under 2 years of age do not use: consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4.00%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

  • Adults and children 2 years of age and older: 
  • shake bottle well 
  • roll a thin layer to each affected area and allow to air dry 
  • repeat 
  • Wash hands after applying product 
  • do not use more than 3 to 4 times daily 
  • children under 2 years of age do not use: consult a doctor

Other Information

SPL UNCLASSIFIED SECTION

Store between 32°F and 120°F

Inactive Ingredients (Alphabetical)

INACTIVE INGREDIENT SECTION

Allantoin, Aloe barbadensis Leaf Extract, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Dimethyl Sulfoxide, Ethylhexylglycerin, Glycerin, Potassium Sorbate, Sanguinaria canadensis Root Extract, Silver Hydrosol, Sodium Benzoate, Tetrasodium EDTA, Xanthan Gum, Yeast Extract, Zingiber (Ginger) Root Extract

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN1
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD1
1987647lidocaine hydrochloride 4 % Topical SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-030-00Theraworx Pain Relief Roll-On with Lidocaine for Diabetics74 mL in 1 BOTTLE, WITH APPLICATORLIQUID741

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-030THERAWORX PAIN RELIEF ROLL-ON WITH LIDOCAINE FOR DIABETICS (LIDOCAINE HYDROCHLORIDE) LIQUID [AVADIM HOLDINGS, INC.]1Current NDC, 1 package rows20240601_e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61594-030-00ML - Milliliter61594-0304c489e9c-92ae-4b53-a4cf-c2782678655e12024-05-16

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61594-03061594-030-00

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
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SANGUINARIA CANADENSIS ROOTN9288CD508IACT
SODIUM BENZOATEOJ245FE5EUIACT
EDETATE SODIUMMP1J8420LUIACT
XANTHAN GUMTTV12P4NEEIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
GINGERC5529G5JPQIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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 Pain Relief Roll-On with Lidocaine for DiabeticsLIDOCAINE HYDROCHLORIDEAVADIM HOLDINGS, INC.e07f5bf7-5a9a-468c-8c3f-2c6f0b17af292024-01-08WarningsExact identifier
ndc (package): 61594-030-00
ndc (product): 61594-030
ndc11 (package): 61594003000
spl id: 0e6c3fd5-9049-2b53-e063-6294a90aeae4
spl set id: e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29

Reported adverse events (FAERS/openFDA)#

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