Drugplain

SionBiotext Hydrocortisone .1 g/g

Hydrocortisone Acetate 1% · CREAM · Sion Biotext Medical Ltd

No Recall HistoryCurrently in Shortage
Plain English

SionBiotext Hydrocortisone is a cream containing hydrocortisone acetate 1% at .1 g/g, taken topical. Manufactured by Sion Biotext Medical Ltd.

Key Facts

Brand Name
SionBiotext Hydrocortisone
Generic Name
Hydrocortisone Acetate 1%
NDC Code (Product)
68786-001
Manufacturer
Sion Biotext Medical Ltd
Strength
.1 g/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
05/13/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

diarrhoea1 reports
gastric haemorrhage1 reports
hepatic enzyme increased1 reports
nephrolithiasis1 reports
renal impairment1 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 oak poison sumac detergents cosmetics jewelry seborrheic dermatitis psoriasis for external genital feminine anal itching

Dosage & Administration

Directions adults and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. children under 2 of age: consult a doctor when used for anal itching cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, painting or blotting with bathroom tissue or soft cloth before applying.

Warnings

Warnings For external use only

Frequently Asked Questions

What is SionBiotext Hydrocortisone used for?

SionBiotext Hydrocortisone contains Hydrocortisone Acetate 1%. It is a cream taken topical. Consult your doctor for specific uses.

Is SionBiotext Hydrocortisone a controlled substance?

SionBiotext Hydrocortisone is not classified as a controlled substance by the DEA.

What is the generic name for SionBiotext Hydrocortisone?

The generic name for SionBiotext Hydrocortisone is Hydrocortisone Acetate 1%. There are 4 other brand versions of Hydrocortisone Acetate 1%.

What is the NDC code for SionBiotext Hydrocortisone .1 g/g?

The NDC (National Drug Code) for SionBiotext Hydrocortisone .1 g/g is 68786-001, listed by Sion Biotext Medical Ltd.

Product NDC

68786-001

Package NDC

68786-001-28

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

Data from openFDA · Public domain (CC0 1.0)