Hydrocortisone Ointment, USP 1%

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by NuCarePharmaceuticals, Inc., NuCare Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
NuCarePharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hydrocortisone Ointment, USP 1%

Drug Facts

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

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 ot 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 59°-86°F (15°-30°C).
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

mineral oil, white petrolatum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL

pdp

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68071-1647(NDC: 0472-0345)
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
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68071-1647-130 g in 1 BOX; Type 0: Not a Combination Product07/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/199812/31/2019
Labeler - NuCarePharmaceuticals, Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals, Inc.010632300relabel(68071-1647)

Revised: 4/2020
Document Id: a3591da2-4733-29d6-e053-2995a90a0eb9
Set id: 51f3d155-36f4-4c40-e054-00144ff8d46c
Version: 2
Effective Time: 20200415
 
NuCarePharmaceuticals, Inc.