Hydrocortisone by TRIFECTA PHARMACEUTICALS USA LLC / Trifecta Pharmaceuticals USA HYDROCORTISONE ointment

Hydrocortisone by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Keep out of the reach of children

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

Uses

temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, 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.

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 itching:

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.

INACTIVE INGREDIENT

Inactive ingredients Light Mineral Oil, Petrolatum

Do Not Use

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.

Other Information

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

Distributed By

Proudly Distributed By:

Associated Wholesale Grocers Inc.

Kansas City, Kansas 66106

Stop using this product and ask a doctor if

• Conidtions 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 any other hydrocortisone product unless directed by a doctor.

When Using This Product

• Avoid contact with 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 fingers or any mechanical device or applicator.

Questions:

Call 1-800-883-0085

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-149
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
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-149-01	1 in 1 BOX	03/14/2024
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	03/10/2024

Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)

Registrant - Trifecta Pharmaceuticals USA (079424163)