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Dermarest psoriasis medicated scalp treatment - Medication Information

Product NDC Code 63736-312
Drug Name

Dermarest psoriasis medicated scalp treatment

Type Brand
Active Ingredients
Salicylic acid 3 g/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 283602
Application Number M032
Labeler Name Insight Pharmaceuticals LLC
Packages
Package NDC Code Description
63736-312-24 24 carton in 1 case (63736-312-24) / 1 bottle in 1 carton / 118 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic acid 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 apply to affected areas one to four times daily or as directed by a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients propylene glycol, purified water, SD alcohol 40, PPG-2 myristyl ether propionate, corn starch modified, zinc PCA, panthenol, aleurites moluccana seed oil, rheum palmatum extract, carthamus tinctorius (safflower) lower extract, camellia sinensis leaf extract, PPG-5-ceteth-20, edetate disodium, xanthan gum, triethanolamine, methylparaben, propylparaben, fragrance

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 and helps prevent recurrence of scalp: itching irritation redness flaking scaling due to psoriasis and seborrheic dermatitis

Purpose

Information about the drug product’s indications for use.
Purposes Psoriasis and seborrheic dermatitis treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Dermarest Psoriasis Medicated Scalp Treatment Salicylic Acid SALICYLIC ACID SALICYLIC ACID PROPYLENE GLYCOL WATER CYCLOMETHICONE 5 CYCLOMETHICONE 4 DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) PPG-2 MYRISTYL ETHER PROPIONATE BIS-PEG-18 METHYL ETHER DIMETHYL SILANE KUKUI NUT OIL ZINC PIDOLATE PANTHENOL GREEN TEA LEAF PHYMATOLITHON CALCAREUM GLYCYRRHIZINATE DIPOTASSIUM RHEUM PALMATUM ROOT SAFFLOWER POLYSORBATE 20 EDETATE DISODIUM ANHYDROUS SODIUM CHLORIDE TROLAMINE METHYLPARABEN PROPYLPARABEN

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 DERMAREST ® Psoriasis SALICYLIC ACID 3% Psoriasis & Seborrheic Dermatitis Gel MAX STRENGTH MEDICATED GEL 4 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton With Scalp Repair Zinc Complex DERMAREST® Psoriasis MEDICATED SCALP TREATMENT SALICYLIC ACID 3% PSORIASIS AND SEBORRHEIC DERMATITIS GEL HELPS ELIMINATE SCALP ITCH Removes and controls crusty build-up ∙ Soothes scalp irritation ∙ Restores moisture With natural extracts LEADER IN PSORIASIS ECZEMA RELIEF 4 FL OZ (118 ml)

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 psoriasis 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 (1-800-222-1222) 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 room temperature 15°-25°C (59°-77°F).

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-344-7239 dermarest.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 the eyes. If contact occurs rinse eyes thoroughly with water.

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 psoriasis that covers a large area of the body When using this product avoid contact with the 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 (1-800-222-1222) 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