LEADER HYDROCORTISONE WITH ALOE .01 g/g

HYDROCORTISONE · CREAM · LEADER

No Recall HistoryCurrently in Shortage

Plain English

LEADER HYDROCORTISONE WITH ALOE is a cream containing hydrocortisone at .01 g/g, taken topical. Manufactured by LEADER.

Key Facts

Brand Name: LEADER HYDROCORTISONE WITH ALOE
Generic Name: HYDROCORTISONE
NDC Code (Product): 70000-0543
Manufacturer: LEADER
Strength: .01 g/g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: M007
Drug Class: Corticosteroid [EPC]
Marketing Start: 01/17/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use9,163 reports

drug ineffective7,258 reports

fatigue5,735 reports

condition aggravated5,322 reports

nausea4,844 reports

rash4,744 reports

diarrhoea4,331 reports

pain4,322 reports

headache4,308 reports

arthralgia4,153 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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, detergents, cosmetics, jewelry and for external anal and genital itching.

Dosage & Administration

Directions For itching associated with minor skin irritations, inflammation, and rashes: Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor For external anal and genital itching: Adults and children 12 years of age and older: when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product apply to affected area not more than 3 to 4 times daily Children under 12 years of age: Consult a doctor

Warnings

Warnings For external use only. Avoid contact with eyes. Do not use if you have a vaginal discharge. Consult a doctor. When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put 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 or clear up and occurs again within a few days bleeding occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Frequently Asked Questions

What is LEADER HYDROCORTISONE WITH ALOE used for?

LEADER HYDROCORTISONE WITH ALOE contains HYDROCORTISONE. It is a cream taken topical. Consult your doctor for specific uses.

Is LEADER HYDROCORTISONE WITH ALOE a controlled substance?

LEADER HYDROCORTISONE WITH ALOE is not classified as a controlled substance by the DEA.

What is the generic name for LEADER HYDROCORTISONE WITH ALOE?

The generic name for LEADER HYDROCORTISONE WITH ALOE is HYDROCORTISONE. There are 12 other brand versions of HYDROCORTISONE.

What is the NDC code for LEADER HYDROCORTISONE WITH ALOE .01 g/g?

The NDC (National Drug Code) for LEADER HYDROCORTISONE WITH ALOE .01 g/g is 70000-0543, listed by LEADER.

Product NDC

70000-0543

Package NDC

70000-0543-1

Other Hydrocortisone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)