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

Antipruritic (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 and rashes

● external feminine, genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Do Not Use

• For the treatment of diaper rash, consult a doctor.
• With any other Hydrocortisone product unless you have consulted a doctor
• If you have a vaginal discharge, consult a doctor

Warnings

For external use only

When using this product

• Avoid Contact with the eyes
• do not exceed the recommended daily dosage unless directed by a doctor.
• 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 if

• conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product.
• Rectal bleeding occurs

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 and ask a doctor.

For External and anal itching in adults:

When practical, clean 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

For External anal and genital itching in children under 12 years of age:

Ask a doctor

Inactive ingredients

Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.

Other information

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

Tamper evident, do not use if packet is torn, cut or opened.

Avoid excessive heat and humidity.

SPL UNCLASSIFIED SECTION

Distributed by:

Trifecta Pharmaceuticals USA™

Ft. Lauderdale, FL 33301 USA

Online: www.trifecta-pharma.com

Reorder No. 1016SL

To reorder call: 1-888-296-9067

Fax: 888-878-3609

Questions

Call 1-888-296-9067

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 1% 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-118
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
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-118-09	144 in 1 CARTON	05/31/2023
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69396-118-25	25 in 1 BOX	05/31/2023
2		0.9 g in 1 PACKET; 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	05/31/2023

Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)