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Sulfur 8 aqua blue - Medication Information

Product NDC Code 12022-024
Drug Name

Sulfur 8 aqua blue

Type Brand
Active Ingredients
Pyrithione zinc 10 mg/ml
Route TOPICAL
Dosage Form SHAMPOO, SUSPENSION
RxCUI drug identifier 209884
Application Number M032
Labeler Name J. Strickland & Co.
Packages
Package NDC Code Description
12022-024-00 222 ml in 1 bottle (12022-024-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Pyrithione Zinc, 1% Purpose Antidandruff

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 well for best results, use twice a week wet hair, apply shampoo, lather, rinse & repeat

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients SD Alcohol 40, Water, Propylene Glycol, Benzyl Alcohol, Menthol.

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.
Use: relieves scalp itching, irritation, redness, scaling and flaking associated with dandruff

Purpose

Information about the drug product’s indications for use.
Purpose Antidandruff

Spl product data elements

Usually a list of ingredients in a drug product.
Sulfur 8 Aqua Blue Pyrithione Zinc WATER AMMONIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE HYPROMELLOSE, UNSPECIFIED GLYCOL STEARATE MAGNESIUM ALUMINUM SILICATE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE TRIETHYLENE GLYCOL MAGNESIUM NITRATE MAGNESIUM CHLORIDE CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 PYRITHIONE ZINC PYRITHIONE ZINC

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.
Package Labeling 12022-024-00

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 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 call a Poison Control Center right away.

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 conditions worsens or does not improve after regular use.

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 get into 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 seborrheic dermatitis that covers a large area of the body. When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and consult a doctor if conditions worsens or does not improve after regular use. Keep out of reach of children If swallowed, get medical help or call 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