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Theraworx joint relief roll on - Medication Information

Product NDC Code 61594-027
Drug Name

Theraworx joint relief roll on

Type Brand
Active Ingredients
Frankincense 8 [hp_x]/ml
Route TOPICAL
Dosage Form LIQUID
Labeler Name AVADIM HOLDINGS, INC.
Packages
Package NDC Code Description
61594-027-00 1 bottle in 1 carton (61594-027-00) / 74 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
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

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses relieves joint discomfort increase range of motion improves daily function

Purpose

Information about the drug product’s indications for use.
Purpose Anti Inflammatory

Spl product data elements

Usually a list of ingredients in a drug product.
Theraworx Joint Relief Roll On FRANKINCENSE ALLANTOIN ALOE VERA LEAF WATER BENZYL ALCOHOL CALCIUM CARBONATE CITRIC ACID MONOHYDRATE COCAMIDOPROPYL BETAINE SILVER CROTON LECHLERI RESIN DECYL GLUCOSIDE ETHYLHEXYLGLYCERIN GLYCERIN PEG/PPG-4/12 DIMETHICONE POTASSIUM SORBATE SODIUM BENZOATE EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE CHASTE TREE FRUIT XANTHAN GUM YEAST, UNSPECIFIED YUCCA SCHIDIGERA WHOLE FRANKINCENSE FRANKINCENSE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package Labeling: Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if unintended effects occur.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid eye contact store between 32°F and 120°F use only as directed not for ingestion

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breastfeeding, ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API