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| Product NDC Code | 55758-420 | ||||
|---|---|---|---|---|---|
| Drug Name | Rapidol |
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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 | 106258 | ||||
| Application Number | M017 | ||||
| Labeler Name | Pharmadel 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 & Purpose Active ingredient Purpose Hydrocortisone 1%............................................... 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 For itchy skin, irritations, inflammation, rashes and external feminine and genital itching: adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. children under 2 years of age: do not use, consult a doctor For external anal itching: adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera leaf, cetostearyl alcohol, dimethicone, dimethyl sulfoxide, edetic acid, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, mineral oil, propylparaben, stearic acid, tocopherol acetate (vitamin E), trolamine, 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 For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema insect bites poison ivy poison oak poison sumac soaps detergent cosmetics jewelry seborrheic dermatitis psoriasis and for external feminine, genital, and anal itching for other uses of this product should only be under the advice and supervision of a doctor
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose Hydrocortisone 1%............................................... Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Rapidol Hydrocortisone ALOE VERA LEAF CETOSTEARYL ALCOHOL DIMETHICONE DIMETHYL SULFOXIDE EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE METHYLPARABEN MINERAL OIL PROPYLPARABEN WATER STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE TROLAMINE HYDROCORTISONE HYDROCORTISONE Off white
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 Rapidol HC1
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 for treatment of diaper rash. Consult a doctor if you have a vaginal discharge. Consult a doctor. with any other hydrocortisone product unless you have consulted a doctor
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 accidental ingestion, seek medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.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 persist for more than 7 days 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 for external anal itching: Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a doctor before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store in a cool dry place do not use if foil seal under cap is torn, broken, or missing
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. Avoid contact with the eyes. Do not use for treatment of diaper rash. Consult a doctor if you have a vaginal discharge. Consult a doctor. with any other hydrocortisone product unless you have consulted a doctor When using this product for external anal itching: Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days and occur again within a few days If pregnant or breastfeeding, ask a doctor before use. Keep out of reach of children. If accidental ingestion, seek medical help or contact a Poison Control Center immediately.
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