THERAWORX JOINT RELIEF ROLL ON- frankincense liquid

Theraworx Joint Relief Roll On by

Drug Labeling and Warnings

Theraworx Joint Relief Roll On 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 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

• relieves joint discomfort
• increase 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 well
• roll a thin layer to each affected area and allow to air dry
• if applicable put on compression
• repeat
• use as needed

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:

INGREDIENTS AND APPEARANCE

THERAWORX JOINT RELIEF ROLL ON 
frankincense liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-027
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 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61594-027-00	1 in 1 CARTON	01/15/2023
1		74 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/15/2023

Labeler - AVADIM HOLDINGS, INC. (118512488)