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| Product NDC Code | 84745-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Poagci ketoconazole vcp-kad001 |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 240812 | ||||
| Application Number | M032 | ||||
| Labeler Name | Vince (Guangzhou) Cosmetics Co., Ltd. | ||||
| 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 Ketoconazole 1% w/w
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.adults and children 12 years and over wet hair thoroughly apply shampoo, generously lather, rinse thoroughly. Repeat use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruf
children under 12 years ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Sodium Lauryl Sulfate, Dimethicone, Dimethiconol, Disodium Laureth Sulfosuccinate, Zinc Pyrithione, Phenoxyethanol, Fragrance, Sodium Cocoyl Alaninate, Caprylyl/Capryl Glucoside, Guar Hydroxypropyltrimonium Chloride, Salicylic Acid, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyquaternium-67, Glycerin, Sodium Hydroxide, Cetrimonium Chloride, Benzoic Acid, Acrylamidopropyltrimonium Chloride/Acrylamide Copolymer, Piroctone Olamine, Laureth-23, Tea-Dodecylbenzenesulfonate, Sodium Polynaphthalenesulfonate, DMDM Hydantoin, Sodium Benzoate, Cellulose Gum, Ethylhexylglycerin, CI 16255
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 controls flaking, scaling and itching associated with dandruff
Purpose
Information about the drug product’s indications for use.Purpose Anti-dandruff shampoo
Spl product data elements
Usually a list of ingredients in a drug product.POAGCI Ketoconazole VCP-KAD001 Ketoconazole PHENOXYETHANOL KETOCONAZOLE KETOCONAZOLE SODIUM LAURETH SULFATE
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 84745-002-01 Label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on scalp that is broken or inflamed if you are allergic to ingredients in this produc
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 rash appears condition worsens or does not improve in 2-4 weeks
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 product gets into eyes, rinse thoroughly with water
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20°C to 25°C (68°F-77°F) see package for lot number and expiration date
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