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| Product NDC Code | 71819-018 | ||||
|---|---|---|---|---|---|
| Drug Name | Dermaharmony tea tree bar |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SHAMPOO | ||||
| RxCUI drug identifier | 244458 | ||||
| Application Number | M032 | ||||
| Labeler Name | D3 Development, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Pyrithione zinc 2%
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 Use on affected areas in place of your regular shampoo For best results use at least twice a week or as directed by a doctor Rub between hands to create a lather, or apply bar directly onto hair Massage into the hair and scalp for 60-90 seconds, then rinse well
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, tea tree (Melaleuca Alternifolia) leaf oil, water, soyethyl morpholinium ethosulfate, coco glucoside, cetearyl alcohol & ceteareth-20, benzyl alcohol, dehydroacetic acid, oat (Avena Sativa) flour, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, sucrose cocoate, sodium isostearoyl lactylate, iron oxides (ochre).
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 Controls and reduces the symptoms of dandruff and seborrheic dermatitis.
Purpose
Information about the drug product’s indications for use.Purpose Dandruff / seborrheic dermatitis shampoo
Spl product data elements
Usually a list of ingredients in a drug product.Dermaharmony Tea Tree Bar Pyrithione Zinc OATMEAL TEA TREE OIL DEHYDROACETIC ACID ARGAN OIL DISODIUM 2-SULFOLAURATE BENZYL ALCOHOL WATER SODIUM ISOSTEAROYL LACTYLATE COCO GLUCOSIDE SODIUM COCOYL ISETHIONATE STEARIC ACID COCONUT ACID PYRITHIONE ZINC PYRITHIONE ZINC SOYETHYL MORPHOLINIUM ETHOSULFATE CETOSTEARYL ALCOHOL SODIUM METHYL 2-SULFOLAURATE SODIUM ISETHIONATE SUCROSE COCOATE POLYOXYL 20 CETOSTEARYL ETHER FERRIC OXIDE YELLOW
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.dermaharmony TEA TREE Shampoo Bar with 2% Pyrithione Zinc FOR DANDRUFF & SEBORRHEIC DERMATITIS NET WT 4 OZ (113G) Dandruff Shampoo 71819-018-04
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
Distributed by: D3 Development, Inc., Portland, ME 04101 Made in USA of U.S. and imported ingredients. NDC Code: 71819-018-04
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 a condition that covers a large area of the body.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-827-3730 www.dermaharmony.com
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 condition worsens or does not improve after regular use as directed.
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 contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature
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 Ask a doctor before use if you have a condition that covers a large area of the body. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use as directed. 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