THERAWORX JOINT RELIEF ROLL ON- 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 Joint Relief Roll On

Drug Facts

Active Ingredient

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

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 (Alphabetical)

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:

Label

THERAWORX JOINT RELIEF ROLL ON 
frankincense liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FRANKINCENSE (UNII: R9XLF1R1WM) (FRANKINCENSE - UNII:R9XLF1R1WM) FRANKINCENSE8 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SILVER (UNII: 3M4G523W1G)  
CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHASTE TREE FRUIT (UNII: 433OSF3U8A)  
XANTHAN GUM (UNII: TTV12P4NEE)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61594-027-001 in 1 CARTON01/15/2023
174 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/15/2023
Labeler - AVADIM HOLDINGS, INC. (118512488)

Revised: 8/2023
Document Id: 0437aa5f-57f9-973a-e063-6294a90a9b30
Set id: 0437aa53-e3e7-0ac6-e063-6394a90a71dd
Version: 1
Effective Time: 20230831
 
AVADIM HOLDINGS, INC.