Avedana ® Maximum Strength Hydrocortisone Ointment

Manufacturer
Unipack, Inc. | ASIAN AEROSOL OAN PRIVATE LIMITED
Effective date
2021-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:36:58

Label at a glance#

ProductHydrocortisone Maximum Strength
Active ingredientHYDROCORTISONE
Label structure13 sections

Indications and 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 genital, feminine and anal itching, other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

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 soft cloth before applicaion of this product. Children under 12 years of a...

Storage and handling

Storage temperature: not to exceed 30oC (86oF). Before using any medication, read all label directions. Keep carton, it contains important information.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone, USP 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

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 genital, feminine and anal itching,

other uses of this product should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • for external feminine itching if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When using this product

INSTRUCTIONS FOR USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 soft cloth before applicaion of this product.

Children under 12 years of age:

  • consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Storage temperature: not to exceed 30oC (86oF).
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

mineral oil, white petrolatum

Avedana ® Maximum Strength Hydrocortisone Ointment | 1oz Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube LabelTube Label

Avedana ® Maximum Strength Hydrocortisone Ointment | 1oz Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton LabelCarton Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-251HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) OINTMENT [UNIPACK, INC.]1Legacy NDC20210905_cb1e7bf4-5d54-5b79-e053-2a95a90a306e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43749-25143749-251-03, 43749-251-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43ace209-0505-7b08-e063-6294a90a7a39cb1e7bf4-5d54-5b79-e053-2a95a90a306e2025-11-15WarningsExact identifier
spl set id: cb1e7bf4-5d54-5b79-e053-2a95a90a306e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.