HYDROCORTISONE- hydrocortisone 1% cream

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by PHARMACY CHOICE INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

eczema
insect bites
poison ivy, oak or sumac
soaps
detergents
cosmetics
jewelry,
seborrheic dermatitis
psoriasis
temporarily relieves external anal and genital itching
Other uses of this product should only be under the advice and supervision of a doctor.

Directions

for itching of skin irritation, inflammation, and rashes:

adults and children 2 years of age 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 anal and genital itching, adults:

when practical, cleanse the 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
apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Warnings

For external use only

Stop use and ask a doctor if

Condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
rectal bleeding occurs.

Keep out of reach of children

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

Other information

store between 20° - 25°C (68° - 77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredients

Aloe oil, Cetostearyl Alcohol, Ethylparaben, Glycerin, Glyceryl Monostearate, Mineral Oil, Petrolatum, Polyoxyl lauryl ether, Purified water, Stearic Acid

Do not use

in the genital area if you have a vaginal discharge.
for the treatment of diaper rash, Consult a doctor.

When using this product

avoid contact with eyes
do not use more than directed unless told to do so by a doctor
do not put directly into the rectum by using fingers or any mechanical device or applicator

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87228-2010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
LAURETH-23 (UNII: N72LMW566G)
STEARIC ACID (UNII: 4ELV7Z65AP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87228-2010-1	28.4 g in 1 TUBE; Type 0: Not a Combination Product	11/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/17/2025

Labeler - PHARMACY CHOICE INC (144879654)

Registrant - PHARMACY CHOICE INC (144879654)