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Dermaharmony zinc therapy - Medication Information

Product NDC Code 71819-016
Drug Name

Dermaharmony zinc therapy

Type Brand
Active Ingredients
Pyrithione zinc 2 g/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1048123
Application Number part358H
Labeler Name D3 Development, Inc.
Packages
Package NDC Code Description
71819-016-04 118 ml in 1 bottle, plastic (71819-016-04)
71819-016-10 296 ml in 1 bottle, plastic (71819-016-10)
71819-016-12 355 ml in 1 bottle, plastic (71819-016-12)
71819-016-64 1893 ml in 1 bottle, plastic (71819-016-64)
71819-016-99 3785 ml in 1 bottle, plastic (71819-016-99)
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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 Shake before each use Use on affected areas in place of your regular soap For best results use at least twice a week or as directed by a doctor Work up a lather using warm water and massage into affected areas Rinse well

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Lauryl Glucoside, Cocamidopropyl Hydroxysultaine, Sodium Lauroamphoacetate, Distearyl Phthalic Acid Amide, Sodium Chloride, Lauramine Oxide, Melaleuca Alternifolia (Tea Tree) Oil, Soyethyl Morpholinium Ethosulfate, Phenoxyethanol, Aloe Barbadensis Leaf Juice

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, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis.

Purpose

Information about the drug product’s indications for use.
Purposes Dandruff, Seborrheic dermatitis

Spl product data elements

Usually a list of ingredients in a drug product.
Dermaharmony Zinc Therapy Pyrithione Zinc SODIUM CHLORIDE LAURYL GLUCOSIDE WATER COCAMIDOPROPYL HYDROXYSULTAINE SOYETHYL MORPHOLINIUM ETHOSULFATE PYRITHIONE ZINC PYRITHIONE ZINC DISTEARYL PHTHALAMIC ACID TEA TREE OIL LAURAMINE OXIDE SODIUM LAUROAMPHOACETATE ALOE VERA LEAF PHENOXYETHANOL

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 Zinc Therapy CLEANSER 2% Pyrithione Zinc for Seborrheic Dermatitis & Dandruff HELPS STOP: FLAKING, REDNESS, IRRITATION, SCALING 4 FL OZ (118 ml) 71819-016 Final

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 from U.S. and imported ingredients

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 seborrheic dermatitis that covers a large portion 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

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 Lot number and expiration date on bottom

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 seborrheic dermatitis that covers a large portion 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