HYDROCORTISONE 1%- hydrocortisone cream

Hydrocortisone 1% by

Drug Labeling and Warnings

Hydrocortisone 1% by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals Usa Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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

Uses

For 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

Do not Use:

For the treatment of a diaper rash, consult with doctor

For external genital itching if you have a vaginal discharge, consult doctor

When using this product

• Avoid Contact with the 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 and consult a doctor.
• do not put this product into the rectum by using fingers or any medicated device or applicator.

Stop using this product and ask a doctor if

• conditions 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 of any other hydrocortisone product unless directed by a doctor.

Directions

Adults and children 2 years of age and older: apply to the 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 ingredients

Ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate

Other information

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

SPL UNCLASSIFIED SECTION

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 1% 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-050
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
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-050-01	1 in 1 BOX	12/12/2019
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	12/12/2019

Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)