FDA.reportPublic FDA data

Hydrocortisone Cream Maximum Strength - Select Brand

Manufacturer
Chain Drug Consortium, LLC
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:36:36

Label at a glance#

ProductHydrocortisone Maximum Strength
Active ingredientHYDROCORTISONE
Label structure10 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone USP, 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Use

INDICATIONS & USAGE SECTION

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
    • eczema
    • psoriasis
    • insect bites
    • poison ivy, oak, sumac
    • detergent
    • jewelry
    • cosmetics
    • soaps seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should be only under the advise 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. Consult a doctor.
  • for the treatment of diaper rash. Consult

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not use more than directed unless directed by a doctor
  • do not put directly into the rectum by 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
  • do not begin the use of any other hydrocortisone product unless directed by 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 a Poison Control Center (1-800-222-1222) right away.

Direction

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: consult a doctor
  • for external anal and genital 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
    • apply to affected area not more than 3 to4 times daily
    • children under 12 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 15º-30ºC (59º-86ºF). Protect from freezing.
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution*, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT IN MAXIMUM STRENGTH CORTIZONE 10®†

MAXIMUM STRENGTH

Hydrocortisone Cream USP, 1%

ANTI-ITCH CREAM

Relieves

Itches and Rashes

NET WT. OZ (g)

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes

†This product is not manufactured or distributed by Chattem, Inc., distributor of Maximum Strength Cortizone 10®.

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREMIER VALUE Maximum Strength Hydrocortisone Cream 1%
PREMIER VALUE Maximum Strength Hydrocortisone Cream 1%

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-90968016-909-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABENA2I8C7HI9TIACT
POLYOXYL STEARATE 4013A4J4NH9IIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBIC ACIDX045WJ989BIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WHITE WAX7G1J5DA97FIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

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
c3809b34-2164-45de-ae7a-3d8d9c5e7ffbcca3f279-e84e-433c-bd58-8782484b19442025-06-25WarningsExact identifier
spl id: c3809b34-2164-45de-ae7a-3d8d9c5e7ffb
spl set id: cca3f279-e84e-433c-bd58-8782484b1944

Reported adverse events (FAERS/openFDA)#

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