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| Product NDC Code | 70631-057 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Thieves essential oil-infused chest rub |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 1297310 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Young Living Essential Oils | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Camphor 5.3% Menthol 2.8% Eucalyptus oil 1.3%
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 Directions See warnings under " When using this product ". Adults and children 2 years and older. For cough suppression rub on throat and chest as a thick layer. Cover with warm, dry cloth if desired • Keep clothing loose about throat and chest to help the vapors rise to reach the nose and mouth. • Use up to 3 times daily or as directed by doctor. For muscle/joint minor aches and pains, apply to the affected area no more than 3—4 times daily. • Children under 2 years: Do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ascorbyl palmitate, Beta-sitosterol, Castor oil, Cinnamon bark oil †, Clove oil †, Eucalyptus radiata †leaf oil, Glyceryl linolenate, Grape seed oil, Helianthus annuus seed wax, Lemon oil †, Olive oil, Rosemary oil †, Safflower oil, Sunflower oil, Squalene, Tocopherol, Toxicodendron vernicifluum fruit rind wax.
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 When applied to chest and throat, temporariliy relieves cough due to minor throat and bronchial irritation associated with the common cold. When applied to muscles and joints, temporarily releives minor aches and pains of muscles and joints. Uses: Changed from "temporarily relieves stuffiness, cough, and congestion due to minor throat and bronchial congestion due to minor throat and bronchial irritation associated with the common cold" to "When applied to chest and throat, temporariliy relieves cough due to minor throat and bronchial irritation associated with the common cold. When applied to muscles and joints, temporarily releives minor aches and pains of muscles and joints." Directions: Changed from: •"See warnings under " When using this product". • Adults and children 2 years and older. • For cough suppression • rub a thick layer on throat and chest. • Use up to three times daily or as directed by doctor. • Children under 2 years: Do not use. Changed to: • See warnings under " When using this product". • Adults and children 2 years and older. • For cough suppression rub on throat and chest as a thick layer. • Cover with warm, dry cloth if desired • Keep clothing loose about throat and chest to help the vapors rise to reach the nose and mouth. • Use up to 3 times daily or as directed by doctor. • For muscle/joint minor aches and pains, apply to the affected area no more than 3—4 times daily. • Children under 2 years: Do not use.
Purpose
Information about the drug product’s indications for use.Purpose Camphor .............Cough Suppressant & Topical Analgesic Menthol ...............Cough Suppressant & Topical Analgesic Eucalyptus oil .....Cough Suppressant
Spl product data elements
Usually a list of ingredients in a drug product.Thieves Essential Oil-Infused Chest Rub CAMPHOR (NATURAL) CAMPHOR (NATURAL) CAMPHOR (NATURAL) EUCALYPTUS RADIATA LEAF OIL SAFFLOWER OIL GLYCERYL LINOLENATE TOCOPHEROL CASTOR OIL OLIVE OIL ASCORBYL PALMITATE SQUALANE CLOVE OIL ROSEMARY OIL TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX CINNAMON BARK OIL SUNFLOWER OIL LEMON OIL GRAPE SEED OIL .BETA.-SITOSTEROL MENTHOL MENTHOL EUCALYPTUS OIL EUCALYPTUS OIL
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.PRINCIPAL DISPLAY PANEL - 50 g Tube Thieves™ Essential Oil-Infused Chest Rub Essential Oil-Infused CHEST RUB Cough suppresant Topical Analgesic Ointment Maximum Strength NET WT 1.76OZ (50g) Young Living Thieves Chest Rub Artwork
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Uses: Changed from "temporarily relieves stuffiness, cough, and congestion due to minor throat and bronchial congestion due to minor throat and bronchial irritation associated with the common cold" to "When applied to chest and throat, temporariliy relieves cough due to minor throat and bronchial irritation associated with the common cold. When applied to muscles and joints, temporarily releives minor aches and pains of muscles and joints." Directions: Changed from: •"See warnings under " When using this product". • Adults and children 2 years and older. • For cough suppression • rub a thick layer on throat and chest. • Use up to three times daily or as directed by doctor. • Children under 2 years: Do not use. Changed to: • See warnings under " When using this product". • Adults and children 2 years and older. • For cough suppression rub on throat and chest as a thick layer. • Cover with warm, dry cloth if desired • Keep clothing loose about throat and chest to help the vapors rise to reach the nose and mouth. • Use up to 3 times daily or as directed by doctor. • For muscle/joint minor aches and pains, apply to the affected area no more than 3—4 times daily. • Children under 2 years: Do not use.
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, or emphysetma
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Questions? call 1-800-371-3515
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 consult a doctor if : cough persists for more than 1 week, tends to recur, is accompanied by fever, rash or persistant headache. A persistent cough may be a sign of a serious condition. muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days.
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 do not heat microwave use near open flame add to hot water or container where heating water May cause splattering and result in burns.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature (68° and 77° F).
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 Avoid contact with eyes. Do not use • by mouth • in nostrils • on wounds or damaged skin • with tight bandages Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, or emphysetma Stop use and consult a doctor if : cough persists for more than 1 week, tends to recur, is accompanied by fever, rash or persistant headache. A persistent cough may be a sign of a serious condition. muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days. When using this product do not heat microwave use near open flame add to hot water or container where heating water May cause splattering and result in burns. Keep out of reach of children.
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