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| Product NDC Code | 82637-9455 | ||||
|---|---|---|---|---|---|
| Drug Name | Anti-itch vulva cream 1 hydrocortisone acetate |
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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 | ||||
| Application Number | M017 | ||||
| Labeler Name | The Honey Pot Company 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 Acetate 1% Purpose Anti-Itch
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: Apply to affected area not more than 3 to 4 times daily. Adults and children 12 years of age and older: Children under 12 years of age: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Adansonia Digitata Seed Oil, Allantoin, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C10-18 Triglycerides, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylhydroxamic Acid, Caprylyl Glyceryl Ether, Ceramide NG, Cetearyl Alcohol, Cetyl Alcohol, Cholesterol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethoxydiglycol, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Limonene, Linalool, Melia Azadirachta Seed Oil, Mentha Piperita (Peppermint) Oil, Myristyl Alcohol, Polyhydroxystearic Acid, Potassium Sorbate, Propanediol, Propolis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Phytate, Sodium Stearoyl Lactylate, Steareth-30, Stearic Acid, Steary Alcohol, Sucrose Palmitate, Theobroma Cacao (Cocoa) Seed Butter, Water, Xanthan Gum
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: For the temporary relief of 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.Anti-Itch Vulva Cream 1 Hydrocortisone Acetate HYDROCORTISONE ACETATE HYDROXYETHYL CELLULOSE, UNSPECIFIED LAVENDER OIL LIMONENE, (+)- LINALOOL, (+/-)- AZADIRACHTA INDICA SEED OIL PEPPERMINT OIL MYRISTYL ALCOHOL POTASSIUM SORBATE PROPANEDIOL PROPOLIS WAX JOJOBA OIL SODIUM BENZOATE PHYTATE SODIUM SODIUM STEAROYL LACTYLATE STEARETH-30 STEARIC ACID STEARYL ALCOHOL SUCROSE PALMITATE COCOA BUTTER WATER XANTHAN GUM ADANSONIA DIGITATA SEED OIL ALLANTOIN ALOE VERA LEAF SHEA BUTTER C10-18 TRIGLYCERIDES CANDELILLA WAX CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCERYL ETHER CERAMIDE NG CETOSTEARYL ALCOHOL CETYL ALCOHOL CHOLESTEROL CITRIC ACID MONOHYDRATE COCONUT OIL DIETHYLENE GLYCOL MONOETHYL ETHER GLYCERYL MONOSTEARATE SUNFLOWER OIL HELIANTHUS ANNUUS SEED WAX HYDROCORTISONE ACETATE HYDROCORTISONE
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.Package Labeling: Label inner_labek
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
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 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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions: For questions and general information visit us at www.thehoneypot.co/contact
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 doctor if: Condition worsens If symptoms persist for more than 7 days, or clear up and reoccur 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.
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 When using this product: avoid contact with eyes. Stop use and ask doctor if: Condition worsens If symptoms persist for more than 7 days, or clear up and reoccur again within a few days Do not use if: you have 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