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Product NDC Code | 71630-169 | ||||
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Drug Name | Deep blue copaiba |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | STICK | ||||
RxCUI drug identifier | 2475356 | ||||
Application Number | M017 | ||||
Labeler Name | doTERRA International, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 10%
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.Menthol 10%…..............................................Topical analgesic
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Cocos Nucifera (Coconut) Oil, Tapioca Starch, Gaultheria Procumbens (Wintergreen) Leaf Oil, Helianthus Annuus (Sunflower) Seed Wax, Copaifera Coriacea/Langsdorffii/Officinalis/Reticulata Resin Oil, Water (Aqua), Sambucus Nigra Fruit Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glyceryl Laurate, Glyceryl Caprylate, Mentha Piperita (Peppermint) Oil, Cinnamomum Camphora (Camphor) Oil, Eucalyptus Globulus Leaf Oil, Tanacetum Annuum Flower/Leaf/Stem Oil, Glyceryl Undecylenate, Cananga Odorata Flower Oil, Capsicum Frutescens Fruit Extract, Glycerin, Lauric Acid, Citric Acid, Chamomilla Recutita (Matricaria) Oil, Helichrysum Italicum Flower/Leaf/Stem Oil
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 for the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Sprains Strains Bruises
Purpose
Information about the drug product’s indications for use.Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Deep Blue Copaiba Menthol GLYCERIN ALMOND OIL HELICHRYSUM ITALICUM FLOWER OIL EUCALYPTUS GLOBULUS LEAF GLYCERYL 1-UNDECYLENATE CANANGA OIL CAPSICUM FRUTESCENS WHOLE MATRICARIA CHAMOMILLA FLOWERING TOP OIL LAURIC ACID WATER COPAIBA OIL PEPPERMINT OIL GAULTHERIA PROCUMBENS LEAF HELIANTHUS ANNUUS SEED WAX MENTHOL MENTHOL COCONUT OIL TANACETUM ANNUUM FLOWERING TOP OIL SAMBUCUS NIGRA SUBSP. CERULEA FRUIT GLYCERYL LAURATE GLYCERYL CAPRYLATE CAMPHOR 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.doTERRA Deep Blue Stick + Copaiba Topical Analgesic Net wt. 1.69 oz/48g Display Panel
Instructions for use
Information about safe handling and use of the drug product.Adults and Children 12 years of age and older: • apply generously to affected area • repeat as necessary, but not more than 3 to 4 times daily Children Under 12 years of Age: consult a doctor Drug Facts Cont.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • Store at a temperature below 38c / 100f •Do not use if seal is broken. • Close cap tightly after use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-411-8151
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 • irritation or redness occur • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs • If pain persists for more than 7 days, or redness is present, or in conditions affecting children under 12 years of age
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 - use only as directed - avoid getting into the eyes or on mucous membranes. If contact occurs, rinse thoroughly with water - do not apply to wounds or damaged skin - do not bandages tightly or use with a heating pad.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care 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.For external use only Allergy alert: Do not use if allergic to salicylates (including aspirin) without consulting a physician.
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