THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMMATION- frankincense 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 Joint Discomfort and Inflammation

Drug Facts

Active Ingredient

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

Anti Inflammatory

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

Inactive Ingredients

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:

Bottle

Package Labeling:101ml

Box

THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMMATION 
frankincense liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FRANKINCENSE (UNII: R9XLF1R1WM) (FRANKINCENSE - UNII:R9XLF1R1WM) FRANKINCENSE8 [hp_X]  in 210 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SILVER (UNII: 3M4G523W1G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61594-013-07210 mL in 1 BOTTLE; Type 0: Not a Combination Product07/11/2020
2NDC:61594-013-03101 mL in 1 BOTTLE; Type 0: Not a Combination Product07/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2019
Labeler - AVADIM HOLDINGS, INC. (118512488)
Establishment
NameAddressID/FEIBusiness Operations
AVADIM HOLDINGS, INC.118512488manufacture(61594-013)

Revised: 4/2023
Document Id: fa2336c3-14e3-920c-e053-6294a90a7f71
Set id: 37c297f6-6b3e-495c-9f72-9327e0638cc5
Version: 6
Effective Time: 20230425
 
AVADIM HOLDINGS, INC.