HYDROCORTISONE- hydrocortisone 1% ointment

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Encube Ethicals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Hydrocortisone USP, 1%

PURPOSE

Anti-itch

USE(S)

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

     ■ eczema ■ psoriasis ■ insect bites ■ poison ivy, oak, sumac

     ■ 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 genital area if you have a vaginal discharge. Consult a doctor.

■ for the treatment of diaper rash. Consult a doctor.

WHEN USING THIS PRODUCT

■ avoid contact with the eyes

■ do not use more than directed unless directed by a doctor

■ do not put directly into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK DOCTOR IF

■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

■ do not begin the use of any other hydrocortisone product unless directed by a doctor

■ rectal bleeding occurs

KEEP OUT OF REACH OF CHILDREN

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

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: consult a doctor

■ for external anal and genital itching

    ■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly

    ■ gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

    ■ apply to affected area not more than 3 to 4 times daily

    ■ children under 12 years of age: consult a doctor

OTHER INFORMATION

■ store at 15°C to 30°C (59°F to 86°F) Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENTS

mineral oil, white petrolatum

QUESTIONS OR COMMENTS?

Call 1-833-285-4151

PRINCIPAL DISPLAY PANEL

Hydrocortisone Ointment USP, 1%

Anti-itch ointment

Net wt. 0.5 oz (14g)

Hydrocortisone Ointment USP, 1%

Anti-itch ointment

Net wt. 1 oz (28g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone 1% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21922-098
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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21922-098-04	1 in 1 CARTON	03/06/2025
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 21922-098-05	1 in 1 CARTON	03/06/2025
2		28 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	03/06/2025

Labeler - Encube Ethicals Private Limited (915834105)

Establishment
Name	Address	ID/FEI	Business Operations
Encube Ethicals Private Limited		725076298	ANALYSIS(21922-098) , LABEL(21922-098) , MANUFACTURE(21922-098) , PACK(21922-098)