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| Product NDC Code | 11509-5101 | ||||
|---|---|---|---|---|---|
| Drug Name | Vagisil anti-itch creme maximum strength sensitive skin formula |
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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 | ||||
| RxCUI drug identifier | 1039349, 1039353 |
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| Application Number | part348 | ||||
| Labeler Name | Combe Incorporated | ||||
| 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 i ngredient s Hydrocortisone Acetate 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 and children 12 years and older Apply to external vaginal area not more than 3 to 4 times a day children under 12 years consult a doctor
| adults and children 12 years and older | Apply to external vaginal area not more than 3 to 4 times a day |
| children under 12 years | consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive i ngredients: water, cetyl ethylhexanoate, glycerin, PEG-40 hydrogenated castor oil, glyceryl dilaurate, dimethicone, colloidal oatmeal, aloe barbadensis leaf extract, sodium polyacrylate, caprylyl glycol, ceteareth-20, glyceryl oleate, acrylates/C10-30 alkyl acrylate crosspolymer, cyclopentasiloxane, trideceth-6, sodium hydroxide, disodium EDTA, sorbic acid, PEG/PPG-18/18 dimethicone, tocopheryl acetate, maltodextrin, phenoxyethanol.
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 For temporary external feminine itching.
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.Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula Hydrocortisone Acetate HYDROCORTISONE ACETATE HYDROCORTISONE WATER CETYL ETHYLHEXANOATE GLYCERIN POLYOXYL 40 HYDROGENATED CASTOR OIL GLYCERYL DILAURATE DIMETHICONE OATMEAL ALOE VERA LEAF SODIUM POLYACRYLATE (2500000 MW) CAPRYLYL GLYCOL POLYOXYL 20 CETOSTEARYL ETHER GLYCERYL OLEATE CARBOMER INTERPOLYMER TYPE A (55000 CPS) CYCLOMETHICONE 5 TRIDECETH-6 SODIUM HYDROXIDE EDETATE DISODIUM SORBIC ACID PEG/PPG-18/18 DIMETHICONE ALPHA-TOCOPHEROL ACETATE MALTODEXTRIN PHENOXYETHANOL
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 Vagisil Sensitive Skin Anti-Itch Creme , 1% Hydrocortisone Net. Wt. 1 oz. (28 g) Vagisil Sensitive Skin Anti-Itch Creme, 1% Hydrocortisone Net. 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.Vagisil Sensitive Skin A nti-Itch Cr e me Drug Facts
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 if you have a vaginal discharge. Consult a physician.
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 if symptoms persist for more than 7 days, or clear up and occur again within a few days.
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 e xternal u se o nly Avoid c ontact with eyes Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not use if you have a vaginal discharge. Consult a physician. 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