HYDROCORTISONE OINTMENT USP, 0.5%

HYDROCORTISONE by

Drug Labeling and Warnings

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

Drug Details [pdf]

HYDROCORTISONE- hydrocortisone ointment 
NuCare Pharmaceuticals,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, 0.5%

Active Ingredient:

Hydrocortisone 5 mg

Purpose:

Anti-itch

Uses:

• for temporary relief of itching associated with minor skin irritations and rashes due to:
• eczema
• insect bites
• soaps and detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• poison ivy , oak or sumac
• 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

• in children under 2 years of age
• if you have a vaginal discharge
• for the treatment of diaper rash

Ask a doctor before use if you have

• external genital or feminine itching
• external anal itching
• bleeding

When using this product

• avoid contact with eyes
• do not exceed the recommended daily dosage 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 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and 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:

For minor skin irritations and rashes,

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily .

For external anal itching:

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or soft cloth before application of this product
• children: under 12 years of age, consult a doctor.

Other information:

• do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
• store at room temperature
• see crimp of tube for Lot Number and Expiration Date

Inactive Ingredients

mineral oil and white petrolatum

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

W5157B

R12/11

HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68071-1844(NDC: 0168-0016)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68071-1844-5	28.35 g in 1 BOX; Type 0: Not a Combination Product	08/22/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/1981	12/31/2019

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-1844)

Revised: 4/2020

Document Id: a36f2f4d-ddc7-bc61-e053-2995a90a25c2

34390-5

Set id: 575c4e1f-b017-c017-e053-2a91aa0acd3e

Version: 2

Effective Time: 20200416

 

NuCare Pharmaceuticals,Inc.