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| Product NDC Code | 73408-633 | ||||
|---|---|---|---|---|---|
| Drug Name | Crane safety 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 | Crane Safety 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 (in each gram) Hydrocortisone 1.0%
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 2 years of age and over: apply to affected area not more than 3 to 4 times daily Children under 2 years: do not use and ask a doctor For external genital itching in adults: when practical, clean 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 applying Children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzoic acid*, chlorphenesin*, citric acid*, emulsifying wax*, ethyl alcohol*, glycerin*, glycerol monostearate*, methylparaben, mineral oil, paraffin*, petrolatum, phenoxyethanol*, polysorbate 80*, propylparaben*, purified water, titanium dioxide*, trisodium citrate*, white wax* May contain*
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 irritation, inflammation and rashes for externalgenital,femine and anal itching other uses for 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.Crane Safety Hydrocortisone Hydrocortisone HYDROCORTISONE HYDROCORTISONE PROPYLPARABEN MINERAL OIL PETROLATUM WATER ALCOHOL METHYLPARABEN PARAFFIN WHITE WAX Crane Safety Hydrocortisone Hydrocortisone HYDROCORTISONE HYDROCORTISONE METHYLPARABEN MINERAL OIL PETROLATUM WATER POLYSORBATE 80 TITANIUM DIOXIDE PHENOXYETHANOL CITRIC ACID MONOHYDRATE GLYCERYL MONOSTEARATE CHLORPHENESIN BENZOIC ACID GLYCERIN TRISODIUM CITRATE DIHYDRATE
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.Crane Safety Hydrocortisone 1% Cream Label Hydrocortisone Cream 1% Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes Product CS93373 0.9 g (1/32 oz) Packets 25/Box CRANE Safety® Crane
Crane Safety Hydrocortisone Label Hydrocortisone Cream 1% Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes Product CS93373 0.9 g (1/32 oz) Packets 25/Box CRANE Safety® Crane S
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 the teatment of diaper rash with any other hydrocortisone product unless you have consulted a doctor if you have vaginal discharge, consult 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 swallowed, get medical help or contact a Poison Control Center 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 room temperature 59º to 86ºF (15º to 30ºC) tamper evident, do not use if packet is toen, cut or opened avoid excessive heat and humidity
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 877.506.4291
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 or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product rectal bleeding occurs
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
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