Avedana Hydrocortisone Cream with Aloe

Manufacturer
Unipack LLC
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:40:08

Label at a glance#

ProductAvedana Hydrocortisone Cream with Aloe
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 gential, 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 solft cloth before application of this product. Children under 12 years o...

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 gential, 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

OTC - WHEN USING 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

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 solft cloth before application of this product.

Children under 12 years of age: consult a doctor

Other information

OTHER SAFETY 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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.

Questions?

OTC - QUESTIONS SECTION

Call 724-733-7381

Avedana ® Hydrocortisone Cream with Aloe| 1oz Tube label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube LabelTube Label

Avedana® Hydrocortisone Cream with Aloe| 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
43749-621AVEDANA HYDROCORTISONE CREAM WITH ALOE (HYDROCORTISONE) CREAM [UNIPACK LLC]3Legacy NDC20230120_ca9315f2-d225-d491-e053-2995a90ac893.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43749-62143749-621-03, 43749-621-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
43ac9996-df11-f29e-e063-6294a90a694eca9315f2-d225-d491-e053-2995a90ac8932025-11-15WarningsExact identifier
spl set id: ca9315f2-d225-d491-e053-2995a90ac893

Reported adverse events (FAERS/openFDA)#

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