FDA.reportPublic FDA data

OREAD GOLD Anti-Itch Foam

Manufacturer
Oread Therapeutics, LLC
Effective date
2020-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:37:57

Label at a glance#

ProductOREAD GOLD Anti-Itch Foam
Active ingredientHYDROCORTISONE
Label structure8 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, or poison sumac,” “soaps,” “detergents,” “cosmetics,” “jewelry,” “seborrheic dermatitis,” “psoriasis Other uses of this product should only be under advice and supervision of a physician

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3-4 times daily. Children under 2 years of age: Do not use, consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone................ 1.00%

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, or poison sumac,” “soaps,” “detergents,” “cosmetics,” “jewelry,” “seborrheic dermatitis,” “psoriasis
  • Other uses of this product should only be under advice and supervision of a physician

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • For the treatment diaper rash.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes.

Stop and ask a doctor if

OTC - STOP USE SECTION

Condition worsens, or symptoms persists for more than 7 days, or clear up and occur again within a few days.

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 3-4 times daily.
  • Children under 2 years of age: Do not use, consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Aqua (Deionized Water), Benzyl Alcohol, Capryl/ Capramidopropyl Betaine, Dehydroacetic Acid Docusate Sodium, Sodium Hydroxide, Tetrasodium EDTA.

Questions?

OTC - QUESTIONS SECTION

1-833-673-2301 (M-F) (9-5pm CST)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63015-24263015-242-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
CAPRYL/CAPRAMIDOPROPYL BETAINE231H3ZT9NEIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE SODIUMMP1J8420LUIACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
07499f03-92b7-a295-e063-6294a90ace684de2874f-9bf7-48a9-a1b2-b5fb5d345bdb2023-10-09WarningsExact identifier
spl set id: 4de2874f-9bf7-48a9-a1b2-b5fb5d345bdb

Reported adverse events (FAERS/openFDA)#

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