HYDROCORTISONE- antipruritic (anti-itch) ointment 
BluePoint Laboratories

----------

Hydrocortisone Ointment, USP 1%

Drug Facts

Active ingredient

Hydrocortisone Acetate USP 1%

Purpose

Antipruritic (Anti-Itch)

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.

Warnings

For external use only

If pregnant or breast-feeding,

ask a health professional before use

Do not use

  • in the eyes
  • for diaper rash
  • for external genital or feminine itching if you have a vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if

  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer than 7 days, or if bleeding occurs near anus when used for anal itching

Keep out of reach of children

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

Directions

Other Information

Inactive Ingredients

Mineral Oil, Sorbitan Sesquioleate, White Petrolatum

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited

Plot No. A327, T.T.C Indl. Area, M.I.D.C

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 01/2022

Label

Hydrocortisone Ointment, USP 1%

Tube

cartonHydrocortisone Ointment, USP 1%

HYDROCORTISONE 
antipruritic (anti-itch) ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-526
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68001-526-451 in 1 CARTON05/17/2023
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/17/2023
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Gopaldas Visram & Co., Ltd858030888manufacture(68001-526)

Revised: 11/2023
Document Id: 09bb81fa-759d-b1b7-e063-6394a90aa2c8
Set id: d6523993-d781-cdbc-e053-2a95a90af191
Version: 5
Effective Time: 20231117
 
BluePoint Laboratories