HYDROCORTISONE- hydrocortisone ointment 
TRIFECTA PHARMACEUTICALS USA LLC

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Hydrocortisone OINTMENT 1%

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.

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 ingredients Light Mineral Oil, White Petrolatum

Other Information

see carton or tube for lot number and expiration date.

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

Packaging

hydrocortisone

HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-003-201 in 1 BOX06/15/2017
128.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-003-444 in 1 BOX02/28/2024
228.4 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:69396-003-333 in 1 BOX02/29/2024
328.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/10/2015
Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 2/2024
Document Id: 1286af63-33fc-5b93-e063-6294a90a9717
Set id: 2999fecb-cb15-4023-ade4-ab5822b094d5
Version: 10
Effective Time: 20240229
 
TRIFECTA PHARMACEUTICALS USA LLC