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 Rugby Laboratories, Trifecta Pharmaceuticals USA LLC. 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, 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.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Warnings

• for external use only
• avoid contact with eyes
• do not put this product into the rectum by using fingers or any mechanical device or applicator

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
• children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton as it contains important information

Do Not Use

• For the treatment of diaper rash, consult a doctor
• For the external genital itching if you have a vaginal discharge, consult a doctor

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.

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, 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

• Do not use, consult a doctor

For External and anal itching

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

by patting or blotting with toilet tissue or a soft cloth before application of this product.

• 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 with external anal itching: consult a doctor.

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)

Other Information

Distributed By:

Rugby Laboratories®

Indianapolis, IN 46268

www.majorpharmaceuticals.com

1-800-616-2471

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

Package Label

INGREDIENTS AND APPEARANCE

HYDROCORTISONE CREAM WITH ALOE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1407
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
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1407-95	1 in 1 BOX	03/08/2024
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	03/08/2024

Labeler - Rugby Laboratories (079246066)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)