HYDROCORTISONE- hydrocortisone cream 1% cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Aldermed Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-itch)

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
  • eczema
  • psoriasis
  • poison ivy
  • poison oak
  • poison sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
• 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

• in the eyes
• for diaper rash
• for genital or feminine itching if you have a vaginal discharge.
• more than the recommended daily dosage unless directed by a doctor.
• this product in the rectum by using fingers or any mechanical device or applicator.

Ask a doctor before use if you are

using any other hydrocortisone product

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 continued to use this or any other hydrocortisone product
• in case of bleeding when used for anal itchingoccurs

Keep out of reach of children

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

Directions

• 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

• when used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying.
• children under 12: consult a doctor before using for anal itching.

Other information

• store at room temperature
• tamper evident. Do not use if seal is torn, cut, or opened.
• see sachet or carton for lot numebr and expiry date

Inactive ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Kathon CG, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

Questions or Comments?

Call 1-833-605-8474 9am-5pm EST M-F

PRINCIPAL DISPLAY PANEL - 28.4 g Carton

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87236-004
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
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87236-004-09	144 in 1 CARTON	01/01/2026
1		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	M017	01/01/2026

Labeler - Aldermed Inc. (144887712)