THERAWORX RELIEF- magnesium sulfate heptahydrate liquid 
AVADIM HOLDINGS, INC.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Theraworx Relief

Drug Facts

Active Ingredient

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

Muscle Soreness Relief

Uses

Warnings

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

When using this product

  • avoid eye contact
  • store between 32°F and 120°F
  • use only as directed
  • not for ingestion

Stop use and ask a doctor if

unintended effects occur.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

Inactive Ingredients

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)

Theraworx Relief 3.4oz/101mL (61594-006-03)

Label

THERAWORX RELIEF 
magnesium sulfate heptahydrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE6 [hp_X]  in 101 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILVER (UNII: 3M4G523W1G)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61594-006-03101 mL in 1 BOTTLE; Type 0: Not a Combination Product11/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/08/2018
Labeler - AVADIM HOLDINGS, INC. (118512488)
Establishment
NameAddressID/FEIBusiness Operations
AVADIM HOLDINGS, INC.118512488manufacture(61594-006)

Revised: 4/2023
Document Id: fa23189d-83cb-4796-e053-6294a90a0ce0
Set id: bcd7e4a6-bc97-418c-a50a-9dbb72f944e2
Version: 5
Effective Time: 20230425
 
AVADIM HOLDINGS, INC.