HYDROCORTISONE- antipruritic (anti-itch) ointment
BluePoint Laboratories

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 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

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: consult a doctor.
When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying.
Children under 12: consult a doctor before using for anal itching.

Other Information

Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
Store at room temperature
Avoid excessive heat
Preserve in well-closed container
See crimp of tube or carton for Lot Number and Expiry Date

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

carton Hydrocortisone Ointment, USP 1%

HYDROCORTISONE
antipruritic (anti-itch) ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68001-526
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68001-526-45	1 in 1 CARTON	05/17/2023
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/17/2023

Labeler - BluePoint Laboratories (985523874)

Name	Address	ID/FEI	Business Operations
Establishment
Gopaldas Visram & Co., Ltd		858030888	manufacture(68001-526)

Revised: 5/2023

Document Id: fbf50285-a761-7ecb-e053-6394a90a39a4

Set id: d6523993-d781-cdbc-e053-2a95a90af191

Version: 4

Effective Time: 20230518

BluePoint Laboratories