Hydrocortisone Anti-Itch Cream 1% Drug Facts

Manufacturer
AKRON PHARMA INC
Effective date
2023-03-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:33:53

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure14 sections

Dosage and administration

for itching of skin irritation, inflammation, and  rashes: 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: ask a doctor for external anal and genital itching, adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth bef...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-itch)

Use

INDICATIONS & USAGE SECTION

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • insect bites
  • poison ivy or sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry,
  • seborrheic dermatitis
  • poison oak
  • psoriasis
  • temporarily relieves external anal and genital itching
  • Other uses of this product should be undertaken only under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the genital area if you have a vaginal discharge.
  • for the treatment of diaper rash, Consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not use more thatn directed unless told to do so by a doctor
  • do not put directly into the rectumby using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens, 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 you have consulted a doctor.
  • rectal bleeding occurs.

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

for itching of skin irritation, inflammation, and rashes:

  • 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: ask a doctor

for external anal and genital itching, adults:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other Information

OTHER SAFETY INFORMATION

• Store at 20-25 C (68-77 F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe vera, benzyl alcohol, glyceryl monostearate, mineral oil, PEG-40, PEG-25, propylene glycol, purified water, squalane, stearic acid.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-225-6999

SPL UNCLASSIFIED SECTION

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

www.akronpharma.com

Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28g28g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-1246-12023-03-26C16284748780-1f386c649-b6c8-0266-e053-dadaa90a7c1aHydrocortisone Anti-Itch Cream 1% Drug Facts
71399-1246-12023-01-30C16284748780-1f386c649-b6c8-0266-e053-dadaa90a7c1aHydrocortisone Anti-Itch Cream 1% Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-1246-1GM - Gram71399-124606a2d97f-db1e-406b-9d46-ebba61e5476a12022-11-07

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-124671399-1246-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
95eea1cc-bf73-4fdc-9532-3fe41547b29bd3dd60a8-b66f-4d32-8e79-7d888d5b64932023-11-22WarningsExact identifier
spl set id: d3dd60a8-b66f-4d32-8e79-7d888d5b6493

Reported adverse events (FAERS/openFDA)#

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