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Hydrocortisone 1%

Dosage form: ointment
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Trifecta Pharmaceuticals Usa Llc
NDC Code: 69396-017

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% ANTIPRURITIC (Anti-Itch)

DRUG FACTS

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, 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 crimp for lot number and expiration date

MAXIMUM STRENGTH

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC


www.trifecta-pharma.com

Packaging

HYDROCORTISONE 1% 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-017
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 
Packaging
#Item CodePackage Description
1NDC:69396-017-201 TUBE in 1 BOX
128.4 g in 1 TUBE
2NDC:69396-017-051 TUBE in 1 BOX
215 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/09/2016
Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)

Revised: 11/2017
 
Trifecta Pharmaceuticals Usa Llc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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