HYDROCORTISONE by Encube Ethicals, Inc. / Encube Ethicals Private Limited HYDROCORTISONE cream

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by Encube Ethicals, Inc., 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.
■ tor the treatment o1 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  isopropyl 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 yearn of age and older: apply to affected area not more than 3 to 4 times daily

■ children under 2 yearn 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 paling or blotting with toilet Issue or a soft cloth before application of this product

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

■ children under 12 yearn of age: consult a doctor

OTHER INFORMATION

■ store at 15°C to 30°C (59°F to 86°8). Protect from freezing.

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

INACTIVE INGREDIENTS

cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution* sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

*Contains one or more of these ingredients to adjust pH

QUESTIONS OR COMMENTS?

Call 1-833-285-4151

PRINCIPAL DISPLAY PANEL

Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 1 oz (28g)

  

Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 0.5 oz (14g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21922-096
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
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21922-096-04	1 in 1 CARTON	02/25/2025
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 21922-096-05	1 in 1 CARTON	02/25/2025
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	02/25/2025

Labeler - Encube Ethicals, Inc. (116982244)

Establishment
Name	Address	ID/FEI	Business Operations
Encube Ethicals Private Limited		725076298	ANALYSIS(21922-096) , LABEL(21922-096) , MANUFACTURE(21922-096) , PACK(21922-096)