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|Product NDC Code||45334-391|
|RxCUI drug identifier||283707|
|Labeler Name||Pharmaceutical Specialties, Inc.|
|Check if available Online||Shop Optum Store - Rx always ships FREE|
Active ingredientA list of the active, medicinal ingredients in the drug product.
Active ingredient Pyrithione zinc 2%
Dosage and administrationInformation 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 For best results use at least twice a week or as directed by a doctor Use on affected areas in place of your regular soap Work up a rich lather using warm water and massage gently into affected areas Rinse well
Inactive ingredientA list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients sodium cocoyl isethionate, stearic acid, coconut acid, water, sodium isethionate, sodium cocoyl glycinate, sodium chloride, petrolatum, sorbitol, cetearyl alcohol, propanediol, ceteareth-20, simethicone, glyceryl stearate, PEG-30 stearate, sorbic acid
Indications and usageA 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
PurposeInformation about the drug product’s indications for use.
Purposes Anti-dandruff, Anti-seborrheic dermatitis
Spl product data elementsUsually a list of ingredients in a drug product.
Vanicream Z-Bar Pyrithione Zinc PEG-30 STEARATE SORBITOL POLYOXYL 20 CETOSTEARYL ETHER STEARIC ACID CETOSTEARYL ALCOHOL DIMETHICONE SILICON DIOXIDE GLYCERYL MONOSTEARATE SORBIC ACID WATER SODIUM COCOYL ISETHIONATE PETROLATUM SODIUM ISETHIONATE COCONUT ACID SODIUM CHLORIDE PROPANEDIOL SODIUM COCOYL GLYCINATE PYRITHIONE ZINC PYRITHIONE ZINC
Package label principal display panelThe 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.
NDC 45334-391-01 DERMATOLOGIST TESTED VANICREAM™ Z-Bar Pyrithione Zinc 2% Seborrheic Dermatitis & Anti-dandruff Medicated Cleansing Bar Free of dyes, fragrance, masking fragrance, lanolin, parabens & formaldehyde releasers Gluten-Free for Sensitive Skin Net Wt 3.53 oz (100 g) label
Spl unclassified sectionInformation 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 Dist. by PHARMACEUTICAL SPECIALTIES, INC., ROCHESTER, MN 55901 1-800-325-8232 www.vanicream.com Made in Canada Vanicream is a trademark, or registered trademark of Pharmaceutical Specialties, Inc. in the US or other countries. ©PSI 2015. All rights reserved. SH21B
Ask doctorInformation 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 childrenInformation 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.
QuestionsA telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-325-8232 www.vanicream.com
Stop useInformation 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 of this product as directed.
When usingInformation 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.
Storage and handlingInformation about safe storage and handling of the drug product.
Other information Store at room temperature
WarningsInformation 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
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