HYDROCORTISONE CREAM- hydrocortisone cream

Hydrocortisone Cream by

Drug Labeling and Warnings

Hydrocortisone Cream by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

• eczema
• seborrheic dermatitis
• psoriasis
• insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• detergents
• cosmetics
• jewelry
• external feminine, genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

• for external use only

Directions

Adults and children 2 years and older

• apply to affected area not more than 3 to 4 times daily

Children under 2 years of age

• do not use, consult a doctor

For external and anal ithcing

• adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
• children under 12 years of age with external anal itching, consult a doctor.

Do Not Use

• For the treatment of diaper rash, consult a doctor
• For external genital itching if you have a vaginal discharge, consult a doctor

When using this product

• avoid contact with the eyes
• do not begin the use of any other hydrocortisone product unless you have consulted a doctor
• for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
• Do not put this product into the rectum by using fingersor any mechanical device or applicator.

Stop Using this product and ask a doctor if

• Conditions worsen
• Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Questions

Call 1-800-883-0085

Inactive Ingredients

Cetyl alcohol, Edetate disodium, methylparaben, mineral oil, mono-and-di-glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate.

Other Information

Store at controlled room temperature 20°C - 25°C (68°F - 77°F).

Other Information

Proudly Distributed By:

Associated Wholesale Grocers, Inc.

Kansas City, Kansas 66106

Label

INGREDIENTS AND APPEARANCE

HYDROCORTISONE CREAM 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-147
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-147-01	1 in 1 BOX	03/01/2024
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/20/2024

Labeler - Trifecta Pharmaceuticals USA (079424163)