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| Product NDC Code | 55910-153 | ||||||||||
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| Drug Name | Simply clean dandruff |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | SHAMPOO | ||||||||||
| RxCUI drug identifier | 209884 | ||||||||||
| Application Number | M032 | ||||||||||
| Labeler Name | Old East Main Co. | ||||||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reactions DISTRIBUTED BY OLD EAST MAIN CO. 1OO MISSION RIDGE GOODLETTSVILLE, TN 37072 100% Satisfaction Guaranteed! (888)309-9030
Active ingredient
A list of the active, medicinal ingredients in the drug product.Acitive 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 shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results 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 lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33
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 helps prevent recurrence of flaking and itching associated with dandruff
Purpose
Information about the drug product’s indications for use.Purpose Anti-dandruff
Spl product data elements
Usually a list of ingredients in a drug product.Simply Clean Dandruff Pyrithione Zinc PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURYL SULFATE SODIUM LAURETH SULFATE GLYCOL DISTEARATE SODIUM CHLORIDE ZINC CARBONATE SODIUM XYLENESULFONATE AMODIMETHICONE (800 CST) COCAMIDOPROPYL BETAINE SODIUM BENZOATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE CITRIC ACID MONOHYDRATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 D&C RED NO. 33
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 STUDIO SELECTION SIMPLY CLEAN DANDRUFF SHAMPOO PYRITHIONE ZINC 1% Compare to Head & Shoulders ® Classic Clean Dandruff Shampoo* For normal or oily hair pH balanced formula PARABEN - PHTHALATE FREE 12.5 FL OZ (370 mL) image description
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.Claims Multiple benefit formula to help: Fight dry scalp Calm itch Relieve irritation Soothe and reduce redness Reduce oilness Prevent flakes Leave hair healthy looking
Disclaimer *This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ® Classic Clean Dandruff Shampoo.
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.Stop use and ask a doctor if condition worsens or does not improve after regular use as directed
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.
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
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