Hydrocortisone 1%
Quality Choice Hydrocortisone Cream 1% MAXIMUM STRENGTH
3d48a3c6-b7d6-6794-e063-6294a90afff9
HUMAN OTC DRUG LABEL
Aug 26, 2025
Chain Drug Marketing Association Inc.
DUNS: 011920774
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LABEL
INDICATIONS & USAGE SECTION
Uses
For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, 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
SPL UNCLASSIFIED SECTION
Distributed by: CDMA, Inc.
Novi, MI. 48375
www.qualitychoice.com
Questions: 800-935-2362
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Hydrocortisone 1%
OTC - PURPOSE SECTION
Purpose
Anti-Itch
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
WARNINGS SECTION
Warnings
For external use only
Do not Use:
For the treatment of a diaper rash, consult with doctor
For external genital itching if you have a vaginal discharge, consult doctor
OTC - WHEN USING SECTION
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
- For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use and consult a doctor.
- do not put this product into the rectum by using fingers or any medicated device or applicator.
OTC - STOP USE SECTION
Stop using this product and ask a doctor if
- 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.
DOSAGE & ADMINISTRATION SECTION
Directions
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use, consult 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 application of this product.
Children: under 12 years of age with external anal itching: consult a doctor.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, Stearic Acid.
STORAGE AND HANDLING SECTION
Other information
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)