HYDROCORTISONE- hydrocortisone 1% ointment 
Weeks & Leo Co., Inc.

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Hydrocortisone Ointment

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

temporarily relieves external anal and genital itching

other uses of this product should be only under the advise and supervision of a doctor

Warnings

For external use only

Do not use

  • for the treatment of diaper rash. Ask a doctor.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.
  • for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

When using this product

  • do not get in the eyes
  • for external anal itching, do not use more than directed unless told to do so by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

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 and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

for external anal itching in adults:

for external anal itching in children under 12 years: ask a doctor

Other information

Inactive ingredient

white petrolatum

Principal Display Panel

HYDROCORTISONE 
hydrocortisone 1% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-268
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11383-268-0128 g in 1 TUBE; Type 0: Not a Combination Product10/01/2023
2NDC:11383-268-0259 g in 1 TUBE; Type 0: Not a Combination Product10/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/01/2023
Labeler - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028manufacture(11383-268)

Revised: 12/2023
Document Id: 0c5325e3-4797-856c-e063-6394a90a1f90
Set id: 0c5325e3-4796-856c-e063-6394a90a1f90
Version: 1
Effective Time: 20231212
 
Weeks & Leo Co., Inc.