Hydrocortisone by Sportpharm LLC HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Hydrocortisone 1.0%

PURPOSE

Purpose

Anti-itch

INDICATIONS & USAGE

Uses

• for the temporary relief of itching associated with minor skin irritations, inflamation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
• other uses of this product should be only under the advice and supervision of a doctor

WARNINGS

Warnings

For external use only

Do not use

• for the treatment of diaper rash
• with anyother Hydrocortisone product unless you have consulted adoctor
• if you have vaginal discharge, consulkt a doctor

Stop use and ask a doctor if

• condition worsens or lasts more than 7 days, or clears and occurs again within a few days
• you begin use of any other Hydrocortisone product unless you have consulted a doctor
• bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• for adults and children (2 years of age and older):apply to affected area 3 to 4 times daily
• children under 12 years of age:for external anal itching, consult a doctor
• children under 2 years of age:do not use, consult a doctor
• adults for external anal itching when practical,cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
• gently dry by patting or botting with toilet tissue or a soft cloth before application of this product

SPL UNCLASSIFIED SECTION

Other information

• store at room temperature (donot freeze)
• tamper evident, do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

QUESTIONS

Questions or Comments?1-800-634-7680

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85766-166(NDC:47682-211)
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
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85766-166-25	25 in 1 BOX	02/24/2026
1		0.9 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 85766-166-10	10 in 1 BOX	02/24/2026
2		0.9 g in 1 POUCH; 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	02/24/2026

Labeler - Sportpharm LLC (125298538)