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| Product NDC Code | 62673-058 | ||||
|---|---|---|---|---|---|
| Drug Name | Denorex extra strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SHAMPOO | ||||
| RxCUI drug identifier | 205023, 1303358 |
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| Application Number | M032 | ||||
| Labeler Name | Neoteric Cosmetics, Inc. | ||||
| 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 Ingredients : 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 Shake well apply to wet hair gently massage into hair and scalp to work up a lather rinse thoroughly and repeat for best results, use at least twice weekly or as directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cocamidopropyl betaine, D&C Red No. 33, D&C Yellow No. 10, dimethicone PEG-8 meadowfoamate, FD&C Blue No. 1, FD&C Yellow No. 6, fragrance, glycol distearate, menthol, panthenol, polyquaternium-10, PPG-2 hydroxyethyl cocamide, propylene glycol, sodium C14-C16 olefin sulfonate, sodium citrate, vitamin E acetate, water
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 Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis Helps prevent recurrence of the symptoms of dandruff, seborrheic dermatitis and psoriasis
Purpose
Information about the drug product’s indications for use.Purpose Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis
Spl product data elements
Usually a list of ingredients in a drug product.Denorex Extra Strength Salicylic Acid WATER SODIUM C14-16 OLEFIN SULFONATE PROPYLENE GLYCOL GLYCOL DISTEARATE MENTHOL COCAMIDOPROPYL BETAINE PANTHENOL .ALPHA.-TOCOPHEROL ACETATE SODIUM CITRATE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 D&C RED NO. 33 FD&C BLUE NO. 1 SALICYLIC ACID SALICYLIC ACID
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 EXTRA STRENGTH DENOREX 3 % Salicylic Acid DANDRUFF Control SHAMPOO + CONDITIONER 10 FL OZ (296 mL) Den0059.jpg EXTRA STRENGTH DENOREX 3 % Salicylic Acid DANDRUFF Control SHAMPOO + CONDITIONER 10 FL OZ (296 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
Other information Store at 20º-25º C (68º – 77º F)
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 a condition 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 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 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 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 a condition 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 of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact 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