Label: HYDROCORTISONE 1%- hydrocortisone acetate ointment
- NDC Code(s): 79503-103-30
- Packager: Ezricare Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 11, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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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 finger or any mechanical device or applicator
Stop use and ask a doctor if • condition worsens or if symptoms persist 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
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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
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Maximum Strength Anti-itch Ointment
Compared to the active ingredient in Cortizone •10®*
Temporary Relief the Discomfort of Itching, Rashes and Irritation on Skin Due to Eczema, Psoriasis and Insect bites
*This product is not affiliated with, manufactured by, or produced by the makers or owners of Cortizone • 10®
Distributed by:
EzriCare, LLC
Lakewood, NJ
www.EzriCare.com
Made in India
- Packaging
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE 1%
hydrocortisone acetate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79503-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) WHITE PETROLATUM (UNII: B6E5W8RQJ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79503-103-30 1 in 1 CARTON 08/19/2021 07/01/2025 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 08/19/2021 07/01/2025 Labeler - Ezricare Llc (117573818)
