Sionbiotext Hydrocortisone Cream
FDA Label NDC 68786-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd for the product Sionbiotext Hydrocortisone (NDC 68786-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each gram), purpose, uses, warnings, do not use, stop use and ask a doctor if, if pregnant or breastfeeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Gram)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breastfeeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions

→ Other

→ Principal Display Panel

Active Ingredient (In Each Gram)

Hydrocortisone Acetate 1%

Purpose

Antipruritic (Anti-Itch)

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

Warnings

For external use only

Do Not Use

in the eyes
for diaper rash
for external genital or feminine itching if you have a vaginal discharge
more than the recommend daily dosage unless directed by a doctor
this product in the rectum by using fingers or any other mechanical device or applicator
if the seal is torn or if the tube is damaged

Stop Use And Ask A Doctor If

condition worsens, or if symptoms persists for more than 7 days or clears up and occurs again within a few days,and do not use this or any other hydrocortisone product
in case of bleeding when used for anal itching

If Pregnant Or Breastfeeding

ask a health professional before use

Keep Out Of Reach Of Children

If swallowed get medical help or contact a Posion Control Center right away

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.