Active Ingredient
Hydrocortisone Acetate USP 1%
Hydrocortisone Ointment
FDA Label NDC 68001-526
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Hydrocortisone (NDC 68001-526). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, if pregnant or breast-feeding,, do not use, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Package Label.Principal Display Panel
Hydrocortisone Ointment, USP 1%
Hydrocortisone Ointment, USP 1%
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