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

For temporarily rellief of 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
• temporarily relieves external anal and genital itching

Other use 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

Stop using this product and ask a doctor

• Conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.
• Rectal bleeding occurs

When using this product

When using this product

• avoid contact with the eyes
• Do not use more than directed unless told to do so by a doctor
• Do not put directly into the rectum by using fingers or any mechanical device or applicator.

Do not use

Do not Use

• In the genital area if you have a vaginal discharge. Consult a doctor.
• For the treatment of diaper rash, Consult a doctor.

Directions

For itching of skin irritation, inflammation, and rashes:

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: ask a doctor

For external anal and genital itching, adults:

• When practical, clean the affected area with mild soap and warm water and rinse thoroughly.
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
• Apply to affected area not more than 3 to 4 times daily

• Children under 12 years of age; ask a doctor.

Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, glycerin, Glycerol Stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2-Phenoxyethanol, Polysorbate 80, Propylene Glycol, purified water, Stearic Acid, Trisodium citrate dihydrate, Vitamin E.

Other Information

• store at controlled room temperature 20°- 25°C (68°-77°F)

Questions

Call 1-888-296-9067

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

This product is not manufactured or distributed by Chattem, Inc. distributor of Cortizone-10.

Package Label

INGREDIENTS AND APPEARANCE

HYDROCORTISONE CREAM 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-096
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
EDETIC ACID (UNII: 9G34HU7RV0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GINGER OIL (UNII: SAS9Z1SVUK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
3-METHYLPENTADECANE (UNII: X64R3JC095)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-096-16	454 g in 1 JAR; Type 0: Not a Combination Product	01/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/13/2022

Labeler - Trifecta Pharmaceuticals USA (079424163)