Avedana Hydrocortisone Cream with Aloe
Avedana Hydrocortisone Cream with Aloe
2a55c426-39b4-4d94-b6b4-6c548c9685e9
HUMAN OTC DRUG LABEL
Jul 13, 2025
Unipack LLC
DUNS: 009248480
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 (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Avedana ® Hydrocortisone Cream with Aloe| 1oz Carton label
INDICATIONS & USAGE SECTION
Uses
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
*eczema *insect bites *poison ivy *poison oak *poison sumac *soaps
*jewelry *detergents *cosmetics *psoriasis *seborrheic dermatitis
*for external gential, feminine and anal itching *other uses of this product should be only under the advice and supervision of a doctor
INACTIVE INGREDIENT SECTION
Inactive ingredients
aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.
OTC - QUESTIONS SECTION
Questions?
724-733-7381
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Hydrocortisone, USP 1%
OTC - PURPOSE SECTION
Purpose
Anti-itch
WARNINGS SECTION
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use
*for external feminine itching if you have a vaginal discharge. Consult a doctor.
*for the treatment of diaper rash. Consult a doctor.
DOSAGE & ADMINISTRATION SECTION
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 *do not use, consult a doctor
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a solft cloth before application of this product.
Children under 12 years of age: consult a 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 directed by a doctor
*for external anal itching
*do not use more than directed unless directed by a doctor
*do not put this product into the rectum by using fingers or any mechanical device or applicator
OTC - STOP USE SECTION
Stop use and ask a doctor if
*symptoms last for more than 7 days *the condition gets worse *symptoms clear up and occur again in a few days
*rectal bleeding occurs, consult doctor promptly
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
OTHER SAFETY INFORMATION
Other information
- Storage temperature: not to exceed 30 °C (86 °F). Protect from freezing.
- Before using any medication, read all label directions. Keep carton, it contains important information.