HYDROCORTISONE- hydrocortisone cream cream

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each gram): Hydrocortisone 1%

PURPOSE

Purpose: anti-itch cream

Uses

Temporarily relieves itching associated with minor skin irritations and rashes due to

• eczema
• insect bites
• poison oak, ivy and sumac
• soaps and detergents
• cosmetics
• jewelry
• psoriasis
• seborrheic dermatitis

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

Warnings: For external use only

Do not get in eyes

Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately call 911 or your clocal emergency provider.

DO NOT USE

Do not use:

• in the eyes or over large portions of the body
• for the treatment of diaper rash
• with any other hydrocortisone product

STOP USE

Stop use and ask a doctor if:

• condition worsens
• condition lasts for more than 7 days
• symptoms clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

DOSAGE & ADMINISTRATION

Directions:

• Adults and children 12 years of age and over: apply topically to the area not more than 3 to 4 times daily.
• Children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

• ointment enclosed in a sealed packet
• avoid excessive heat
• do not use if packet is torn, cut or open
• store at 59° to 86°F (15°-30°C)

INACTIVE INGREDIENT

Inactive Ingredients: Cetearyl Alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Mineral Oil, White Petrolatum, Phenoxyethanol, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0092
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-20 (UNII: YRC528SWUY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0092-1	10 in 1 BOX, UNIT-DOSE	08/14/2025
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0092-2	25 in 1 BOX, UNIT-DOSE	08/14/2025
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 50332-0092-4	144 in 1 BOX, UNIT-DOSE	08/14/2025
3		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 Drug	M	08/14/2025

Labeler - HART Health (069560969)