HYDROCORTISONE CREAM 1% WITH ALOE VERA- hydrocortisone cream

Hydrocortisone Cream 1% with Aloe Vera by

Drug Labeling and Warnings

Hydrocortisone Cream 1% with Aloe Vera by is a Otc medication manufactured, distributed, or labeled by Ezricare Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Hydrocortisone USP 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema  seborrheic dermatitis  psoriasis   Insect bites  poison ivy, poison oak, and poison sumac  cosmetics  jewelry   detergents  soaps  temporarily relieves external anal and genital 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 diaper rash. Ask a doctor.  for external genital itching if you have a vaginal discharge. Ask a doctor.   for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

When using this product do not get into the eyes  for external anal itching, do not use more than directed, unless told so by a doctor.  do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily.  children under 2 years: ask a doctor   For external anal itching in adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad  gently dry by patting or blotting with toilet tissue or soft cloth before applying  for external anal itching in children under 12 years: ask a doctor

Other information

Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal Store at room temperature See crimp of tube or carton for Lot Number and Expiration Date

Inactive ingredients

Aloe Vera Leaf, Cetostearyl Alcohol, Glyceryl Stearate SE, Methylisothiazolinone, Propylene Glycol, Water, Stearic Acid, Trolamine, White Petrolatum

SPL UNCLASSIFIED SECTION

Maximum Strength Anti-itch Cream

Compared to the active ingredient in Cortizone 10®

*Cortizone 10®*
*This product is not affiliated with, manufactured by, or produced by the makers or owners of Cortisone 10

Distributed by.

EzriCare, LLC

Lakewood, NJ

www.EzriCare.com

Made in India

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE CREAM 1% WITH ALOE VERA 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79503-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79503-202-30	1 in 1 CARTON	06/01/2021	07/01/2025
1		30 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	06/01/2021	07/01/2025

Labeler - Ezricare Llc (117573818)