Active Ingredient
Hydrocortisone 1%
Hydrocortisone Cream With Aloe Cream
FDA Label NDC 70000-0662
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110 Dba Leader for the product Hydrocortisone Cream With Aloe (NDC 70000-0662). 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, keep out of reach of children, warnings, stop using this product and ask a doctor, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Itch
Uses
For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- seborrheic dermatitis
- psoriasis
- insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- external feminine, genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Warnings
- for external use only
Stop Using This Product And Ask A Doctor
- conditions worsen
- symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Do Not Use
For the treatment of diaper rash, consult a doctor.
For external genital itching if you have a vaginal discharge, consult a doctor.
When Using This Product
- Avoid contact with the eyes.
- Do not begin the use of any other hydrocortisone product unless you have consulted a doctor
- Do not exceed the recommended daily dosage unless directed by a doctor.
- In case of bleeding, stop use, consult a doctor
- Do not put this product into the rectum by using fingers or any mechanical device or applicator
Directions
Adults and children 2 years and older
apply to affected area not more than 3 to 4 times daily
Children under 2 years of age, ask a doctor
For external and anal itching
adults, when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before applicaiton of this product.
Inactive Ingredients
Aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, methylparaben, mineral oil, mono-and-di-glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate.
Other Information
- store at controlled room temperature 20°-25°C (68°-77°F)
- Tamper Evident: do not use if the seal on the tube is punctured or not visible.
Distributed By:
CARDINAL HEALTH
CAH Dublin, OH 43017
www.myleader.com
©2023 CARDINAL HEALTH. All rights reserved CARDINAL HEALTH LOGO, ESSENTIAL TO CARE, and the LEADER LOGOs are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.
1-800-200-6313
*This product is not manufactured or distributed by Chattem Inc. owner of the registered trademark Cortizone 10®
CIN 5878020
Questions
Call 1-888-296-9067
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