Theraworx Relief Joint Discomfort and Inflammation: Homeopathic Product Information

THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMMATION- frankincense liquid
Avadim Health, 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.

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:

Bottle
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRANKINCENSE (FRANKINCENSE) FRANKINCENSE 8 [hp_X] in 210 mL
Inactive Ingredients
Ingredient Name Strength
WATER
COCAMIDOPROPYL BETAINE
ALOE VERA LEAF
CROTON LECHLERI RESIN
CALCIUM CARBONATE
SILVER
.ALPHA.-TOCOPHEROL ACETATE
GLYCERIN
ALLANTOIN
GRAPEFRUIT
LAURYL GLUCOSIDE
EDETATE SODIUM
PEG/PPG-4/12 DIMETHICONE
METHYLPARABEN
PROPYLPARABEN
YUCCA SCHIDIGERA WHOLE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61594-013-07 210 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/11/2020
Labeler — Avadim Health, Inc. (041443877)
Establishment
Name Address ID/FEI Operations
Avadim Health, Inc. 041443877 manufacture (61594-013)

Revised: 07/2020 Avadim Health, Inc.

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