HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream

Hydrocortisone Cream with Aloe by

Drug Labeling and Warnings

Hydrocortisone Cream with Aloe by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110 dba LEADER, Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• seborrheic dermatitis
• psoriasis
• insect bites
• poison ivy
• poison oak
• poison 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

Keep out of reach of children

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

Warnings

• for external use only

Stop using this product and ask a doctor

• 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.

Do Not Use

For the treatment of diaper rash, consult a doctor.

For external genital itching if you have a vaginal discharge, consult a 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
• Do not exceed the recommended daily dosage unless directed by a doctor.
• In case of bleeding, stop use, consult a doctor
• Do not put this product into the rectum by using fingers or any mechanical device or applicator

Directions

Adults and children 2 years and older

apply to affected area not more than 3 to 4 times daily

Children under 2 years of age, ask 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 applicaiton of this product.

Inactive Ingredients

Aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, methylparaben, mineral oil, mono-and-di-glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate.

Other Information

• store at controlled room temperature 20°-25°C (68°-77°F)
• Tamper Evident: do not use if the seal on the tube is punctured or not visible.

Other Information

Distributed By:

CARDINAL HEALTH

CAH Dublin, OH 43017

www.myleader.com

©2023 CARDINAL HEALTH. All rights reserved CARDINAL HEALTH LOGO, ESSENTIAL TO CARE, and the LEADER LOGOs are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

1-800-200-6313

*This product is not manufactured or distributed by Chattem Inc. owner of the registered trademark Cortizone 10®

CIN 5878020

Questions

Call 1-888-296-9067

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE CREAM WITH ALOE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0662
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
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
MINERAL OIL (UNII: T5L8T28FGP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PETROLATUM (UNII: 4T6H12BN9U)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0662-1	1 in 1 BOX	04/16/2024
1		28 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 Drug	M017	04/16/2024

Labeler - Cardinal Health 110 dba LEADER (063997360)

Registrant - Trifecta Pharmaceuticals USA (079424163)