Hydrocortisone Ointment Maximum Strength - Actavis

Manufacturer
Proficient Rx LP
Effective date
2021-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:53:52

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 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 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

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

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 application of this product 
Children under 12 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature 59°-86°F (15°-30°C).
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, white petrolatum

Questions?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:

Actavis Pharma Inc.

Parsippany, NJ 07054

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Proficient Rx
NDC 71205-034-30
Compare to the active ingredient in Cortizone•10®*

Maximum Strength
Hydrocortisone Ointment, USP 1%
Anti-Itch Ointment

Relieves Itches and Rashes
Net wt. 1 oz (28g)

For the temporary relief of itches and rashes due to:
• Insect Bites     • Eczema     • Seborrheic dermatitis
• Poison Ivy, oak & sumac

71205-034-30
71205-034-30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-034-30GM - Gram71205-0342d525ac9-8536-4b0b-ab2c-d7c4a901c35112018-07-03
0472-0345-56GM - Gram0472-0345897e0f9f-c97b-409b-8f0d-3b0be9dea5f512012-07-24

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
71205-03471205-034-30
0472-0345

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
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT

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
1d726fc8-a03f-4b70-a344-b2993684c179b7ff20ee-b092-4831-bfe7-517d4c2558e82024-10-01WarningsExact identifier
spl set id: b7ff20ee-b092-4831-bfe7-517d4c2558e8

Reported adverse events (FAERS/openFDA)#

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