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 relieves 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 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 ●avoid contact with the eyes

●do not put this product into the rectum by using fingers or any mechanical device or applicator.

• Stop using this product and ask a doctor ● in case of bleeding
• if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days 
• before you begin using any other hydrocortisone product. 

Do not use this product and ask a doctor

●if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age.

For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor
● in case of bleeding, consult a doctor promptly
● do not put this product into the rectum by using fingers or any mechanical device or applicator
● children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton. It contains important information.

Directions

 ●when practical, cleanse 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

●adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily

●children under 12 years of age: Do not use, consult a doctor

INACTIVE INGREDIENT

Inactive ingredients Light Mineral Oil, White Petrolatum

Other Information

• to open: unscrew cap and pull tab to remove foil seal
• if seal has been broken, do not use this product. Return product to the Store where you bought it
• store at controlled room temperature 15°-30°C (59°- 86°F)

see carton or tube for lot number and expiration date.

SPL UNCLASSIFIED SECTION

Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
1-888-296-9067

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-003
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: 69396-003-20	1 in 1 BOX	06/15/2017
1		28.4 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 not final	part348	03/10/2015

Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)

Registrant - Trifecta Pharmaceuticals USA (079424163)