SIONBIOTEXT HYDROCORTISONE- hydrocortisone acetate 1% cream

SionBiotext Hydrocortisone by

Drug Labeling and Warnings

SionBiotext Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Other Information

• Store at 15°-30°C (59°-86°F)
• avoid excessive heat and humidity

Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Mineral Oil, Propylene Glycol, Sodium metabisulfite, Water, White Petrolatum

Questions

info@sionbrands.com

Unclassified Section

Distributed by: SIonBrands LLC

16950 Via de Santa Fe, Rancho Santa Fe, CA, 92067

Mail Address: PO Box 450638, Laredo, TX, 78045

Email: info@sionbrands.com

Made in India

Principal Display Panel

NDC: 68786-001-28

SIONBIOTEXT

Hydrocortisone Cream 1%

Relief of Minor Skin Irritiation Itching and Rashes

For Personal and Professional Use

Net Wt: 1.0 oz (28.3g)

INGREDIENTS AND APPEARANCE

SIONBIOTEXT HYDROCORTISONE 
hydrocortisone acetate 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETEARETH-20 (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
EDETATE SODIUM (UNII: MP1J8420LU)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-001-28	28.3 g in 1 BOX; Type 0: Not a Combination Product	05/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/13/2025

Labeler - Sion Biotext Medical Ltd (532775194)