Hydrocortisone by Walgreens Co. / Encube Ethicals Private Limited HYDROCORTISONE ointment

Hydrocortisone by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Hydrocortisone, USP 1%

PURPOSE

Anti-itch

USE(S)

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• jewelry
• detergents
• cosmetics
• psoriasis
• seborrheic dermatitis
• for external genital, feminine and anal 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

• for external feminine itching 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 begin the use of any other hydrocortisone product unless directed by a doctor
• for external anal itching:
• do not use more than directed unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK A DOCTOR IF

• symptoms last for more than 7 days
• the condition gets worse, symptoms clear up and occur again in a few days
• rectal bleeding occurs, consult doctor promptly

KEEP OUT OF REACH OF CHILDREN

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

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 do not use, consult a doctor.

For external anal 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.

Children under 12 years of age: consult a doctor

OTHER INFORMATION

• Store at room temperature 590-860F (150-300C). Protect from freezing. 
• Before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENT

cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax, May contain citric acid or sodium citrate solution to adjust pH.

QUESTIONS?

1-833-285-4151 between 9 am and 4 pm EST, Monday-Friday. 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1333
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)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
POLYSORBATE 40 (UNII: STI11B5A2X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WHITE WAX (UNII: 7G1J5DA97F)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1333-01	1 in 1 CARTON	03/06/2025
1		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 - Walgreens Co. (008965063)

Registrant - Encube Ethicals Private Limited (915834105)

Establishment
Name	Address	ID/FEI	Business Operations
Encube Ethicals Private Limited		725076298	ANALYSIS(0363-1333) , LABEL(0363-1333) , MANUFACTURE(0363-1333) , PACK(0363-1333)