THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMMATION- frankincense liquid

Theraworx Relief Joint Discomfort and Inflammation by

Drug Labeling and Warnings

Theraworx Relief Joint Discomfort and Inflammation by is a Homeopathic medication manufactured, distributed, or labeled by AVADIM HOLDINGS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• relives joint discomfort
• increases range of motion
• improves daily function

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 bottle well
• apply 2 pumps to each affected area
• rub in briskly until absorbed
• repeat
• allow to air dry
• if applicable put on compression
• use as needed

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:

Package Labeling:101ml

INGREDIENTS AND APPEARANCE

THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMMATION 
frankincense liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FRANKINCENSE (UNII: R9XLF1R1WM) (FRANKINCENSE - UNII:R9XLF1R1WM)	FRANKINCENSE	8 [hp_X]  in 210 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61594-013-07	210 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2020
2	NDC: 61594-013-03	101 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2019

Labeler - AVADIM HOLDINGS, INC. (118512488)

Establishment
Name	Address	ID/FEI	Business Operations
AVADIM HOLDINGS, INC.		118512488	manufacture(61594-013)