Theraworx Relief

Manufacturer
AVADIM HOLDINGS, INC.
Effective date
2024-06-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:27:23

Label at a glance#

ProductTheraworx Relief
Active ingredientMAGNESIUM SULFATE HEPTAHYDRATE
Label structure6 sections

Indications and uses

prevents cramps and spasms releases muscle tightness relieves muscle soreness

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Contains Magnesium Sulfate (Magnesia sulphurica) 6X 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

Muscle Soreness Relief

Uses

INDICATIONS & USAGE SECTION

  • prevents cramps and spasms
  • releases muscle tightness
  • relieves muscle soreness

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 • apply 2 pumps onto entire area • briskly rub in until absorbed • repeat • allow to air dry • use as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Colloidal Silver, Tocopheryl Acetate, Glycerin, Allantoin, Beta Glucan, Citrus Paradisi (Grapefruit) Fruit Extract, Lauryl Glucoside, Tetrasodium EDTA, PEG/PPG-4/12 Dimethicone, Methylparaben, Propylparaben, Parfum (Fragrance)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-007-17Theraworx Relief506 mL in 1 BOTTLELIQUID5066

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-007THERAWORX RELIEF (MAGNESIUM SULFATE HEPTAHYDRATE) LIQUID [AVADIM HOLDINGS, INC.]6Current NDC, Legacy NDC, 1 package rows20240619_2da384c4-3559-45aa-a7db-4e2269e33fa7.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
61594-00761594-007-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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 ReliefMAGNESIUM SULFATE HEPTAHYDRATEAVADIM HOLDINGS, INC.2da384c4-3559-45aa-a7db-4e2269e33fa72024-06-18WarningsExact identifier
ndc (package): 61594-007-17
ndc (product): 61594-007
ndc11 (package): 61594000717
spl id: 1b2fe368-dfc5-2c2f-e063-6294a90a7767
spl set id: 2da384c4-3559-45aa-a7db-4e2269e33fa7

Reported adverse events (FAERS/openFDA)#

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