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| Product NDC Code | 63736-029 | ||||
|---|---|---|---|---|---|
| Drug Name | Monistat complete care instant itch relief |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M017 | ||||
| Labeler Name | Insight Pharmaceuticals LLC | ||||
| 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 Hydrocortisone 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 adults: apply to affected area not more than 3-4 times daily children under 12 years of age : ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive i ngredients aloe vera leaf, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, polyoxyl 20 cetostearyl ether, 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 temporarily relieves external genital itching other uses of this product should be only under the advice and supervision of a physician
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Monistat Complete Care Instant Itch Relief hydrocortisone HYDROCORTISONE HYDROCORTISONE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER CARBOMER HOMOPOLYMER TYPE A CETEARETH-6 CETYL ALCOHOL CITRIC ACID MONOHYDRATE DIMETHICONE EDETATE DISODIUM ETHYLPARABEN GLYCERIN METHYLPARABEN MINERAL OIL PETROLATUM PHENOXYETHANOL PROPYLPARABEN SODIUM CITRATE SODIUM HYDROXIDE STEARYL ALCOHOL WATER VINYLPYRROLIDONE/EICOSENE COPOLYMER
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 MONISTAT Care ® Itch Relief Cream Hydrocortisone 1% NEW WT 1 OZ (28 g) PRINCIPAL DISPLAY PANEL MONISTAT Care® Itch Relief Cream Hydrocortisone 1% NEW WT 1 OZ (28 g)
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
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 vaginal discharge.
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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store at 20°-25°C (68°-77°F). Protect from freezing and excessive heat.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-666-4782 Monistat.com
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 symptoms last for more than 7 days or clear up and occur again within a few days
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 do not use more than directed do not begin use of any other hydrocortisone product unless you have asked a doctor
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 vaginal discharge. When using this product avoid contact with eyes do not use more than directed do not begin use of any other hydrocortisone product unless you have asked a doctor Stop use and ask a doctor if condition worsens symptoms last for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) 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