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| Product NDC Code | 51870-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Elementz |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SHAMPOO | ||||
| RxCUI drug identifier | 209884 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Keefe Group | ||||
| 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 1%
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 • wet hair, massage shampoo into scalp • rinse and repeat if desired • for maximum dandruff control, use at least twice a week or as directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide DEA, Sodium Chloride, Styrene/Acrylates Copolymer, Coco-Glucoside, Polyquaternium-7, Fragrance, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium Chloride, Citric Acid, Shea Butter, Sweet Almond Oil.
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 helps prevent recurrence of flaking and itching associated with dandruff
Purpose
Information about the drug product’s indications for use.Purpose Antidandruff shampoo
Spl product data elements
Usually a list of ingredients in a drug product.Elementz Pyrithione Zinc MAGNESIUM CHLORIDE CITRIC ACID MONOHYDRATE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) COCO GLUCOSIDE EDETATE SODIUM TETRAHYDRATE WATER SODIUM LAURETH SULFATE COCO DIETHANOLAMIDE SODIUM CHLORIDE ALMOND OIL SHEA BUTTER METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE PYRITHIONE ZINC PYRITHIONE ZINC POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) MAGNESIUM NITRATE
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.ELEMENTZ™ WITH MOISTURIZING ALMOND OIL & SHEA BUTTER PYRITHIONE ZINC DANDRUFF SHAMPOO FOR DRY & ITCHY SCALP 15 FL OZ | 443 mL label
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: Keefe Supply Company Bridgeton, MO 63044 800-325-8998 Made in Colombia
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Warning: This product can expose you to chemicals including Cocamide DEA, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov
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 of this product 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.
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.
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