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Hydrocortisone 1% with healing aloe - Medication Information

Product NDC Code 69396-005
Drug Name

Hydrocortisone 1% with healing aloe

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
69396-005-05 1 tube in 1 box (69396-005-05) / 15 g in 1 tube
69396-005-20 1 tube in 1 box (69396-005-20) / 28.4 g in 1 tube
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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 ●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 applying. ●adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily. ●children under 12 years of age: do not use, consult a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate

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 temporary relieves itching associated with minor skin irritations, inflammation and rashes due to: ● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps ● detergents ● cosmetics ● jewelry ● external 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 Anti-Itch

Spl product data elements

Usually a list of ingredients in a drug product.
Hydrocortisone 1% with healing aloe Hydrocortisone ALOE VERA LEAF ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE CETYL ALCOHOL STEARYL ALCOHOL PETROLATUM WATER SODIUM LAURYL SULFATE 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.
Packaging Hydrocortisone new1

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™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL 33301 USA Product of PRC www.trifecta-pharma.com

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information ● to open: unscrew cap and pull tab to remove foil seal ● if seal has been broken, do not use this product. Return product to the Store where you bought it ● store at controlled room temperature 15°-30°C ( 59 °- 86 °F) see carton or tube crimp for lot number and expiration date

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 put this product into the rectum by using fingers or any mechanical device or applicator ● Stop using this product and ask a doctor ● in case of bleeding ● if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ● before you begin using any other hydrocortisone product Do not use this product and ask a doctor ● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age For External Anal Itching Users: ● 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 ● children under 12 years of age: consult a doctor Before using any medication, read all label directions. Keep this carton. It contains important information.

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