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Hydrocortisone by TRIFECTA PHARMACEUTICALS USA LLC

Medically reviewed on Nov 20, 2017

Dosage form: ointment
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: TRIFECTA PHARMACEUTICALS USA LLC
NDC Code: 69396-003

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

  • 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 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.

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

Packaging

HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL 
PETROLATUM 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69396-003-201 TUBE in 1 BOX
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/10/2015
Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
Registrant - Trifecta Pharmaceuticals USA (079424163)

 
TRIFECTA PHARMACEUTICALS USA LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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