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Hydrocortisone 1% - Medication Information

Product NDC Code 69396-118
Drug Name

Hydrocortisone 1%

Type Brand
Pharm Class Corticosteroid Hormone Receptor Agonists [MoA],
Corticosteroid [EPC]
Active Ingredients
Hydrocortisone 1 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 106258
Application Number part348
Labeler Name Trifecta Pharmaceuticals Usa Llc
Packages
Package NDC Code Description
69396-118-09 144 packet in 1 carton (69396-118-09) / .9 g in 1 packet
69396-118-25 25 packet in 1 box (69396-118-25) / .9 g in 1 packet
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Hydrocortisone 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 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 and ask a doctor. For External and anal 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 For External anal and genital itching in children under 12 years of age: Ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, 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 temporary relief of itching associated with minor skin irritations and rashes ● external feminine, genital 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 1% Hydrocortisone PHENOXYETHANOL MINERAL OIL GLYCERIN GLYCERYL MONOSTEARATE PETROLATUM WATER HYDROCORTISONE HYDROCORTISONE POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN

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.
Globe Hydrocortisone Cream 0.9g CDER

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 Distributed by: Trifecta Pharmaceuticals USA™ Ft. Lauderdale, FL 33301 USA Online: www.trifecta-pharma.com Reorder No. 1016SL To reorder call: 1-888-296-9067 Fax: 888-878-3609

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 treatment of diaper rash, consult a doctor. With any other Hydrocortisone product unless you have consulted a doctor If you have a 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 the reach of children. If swallowed, get 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 Call 1-888-296-9067

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 using this product and ask a doctor if conditions 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

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 the eyes do not exceed the recommended daily dosage unless directed by a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator.

Storage and handling

Information about safe storage and handling of the drug product.
Other information ● store at controlled room temperature 20°-25°C ( 68 °- 77 °F) Tamper evident, do not use if packet is torn, cut or opened. Avoid excessive heat and humidity.

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