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| Product NDC Code | 68599-1182 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone |
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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 | part348 | ||||
| Labeler Name | McKesson | ||||
| 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.Hydrocortisone Cream 1% Active Ingredients (in each gram) Hydrocortisone USP 10 mg
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 adults and children 2 years of age and older: apply externally to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years or age; for external anal itching, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate.
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.Indications: For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis scrapes For the temporary relief of external genital, feminine and anal itching Other uses of this product should be only under the advice and supervision of a doctor
Purpose
Information about the drug product’s indications for use.Purpose Antipruritic (Anti Itch)
Spl product data elements
Usually a list of ingredients in a drug product.Hydrocortisone Hydrocortisone Cream CITRIC ACID MONOHYDRATE POLYSORBATE 80 TRISODIUM CITRATE DIHYDRATE GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN MINERAL OIL PHENOXYETHANOL BENZOIC ACID WATER TITANIUM DIOXIDE CHLORPHENESIN PETROLATUM HYDROCORTISONE 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.NDC 68599-1182-2 Hydrocortisone Cream 1% Maximum Strength Effective itch and rash relief cream. NET WEIGHT 0.9 g (0.03 oz) MFR # 118-82464 118-82464 Each
NDC 68599-1182-2 McKesson Hydrocortisone Cream 1% Maximum Strength NET WEIGHT 0.9 g (0.03 oz) 144 PACKS PER BOX MFR # 118-82464 118-82464 Box
NDC 68599-1182-2 McKesson Hydrocortisone Cream 1% Maximum Strength NET WEIGHT 0.9 g (0.03 oz) 144 PACKS PER BOX 12 BOXES PER CASE MFR # 118-82464 118-82464 Case
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
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 1-800-222-1222
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 controlled room temperature 59* to 86*F (15* to 30*C) Avoid excessive heat and humidity Tamper Evident. Do not use if packet is torn, cut or opened
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-777-4908
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.Do Not Use: With any other Hydrocortisone product unless you have consulted 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 Avoid contact with eyes Do not exceed the recommended daily dosage unless directed by a doctor Do no use for treatment of diaper rash In case of bleeding, consult a doctor promptly Consult a doctor: Before use if you have a vaginal discharge (for external feminine itching) For external itching, do not exceed the recommended daily dosage or if bleeding occurs If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days discontinue use of this product When using this product: Do not put this product into rectum by using fingers or any mechanical device or applicator
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