FDA.reportPublic FDA data

1% Hydrocortisone Cream MAXIMUM STRENGTH

Manufacturer
Trifecta Pharmaceuticals Usa Llc
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:17:39

Label at a glance#

ProductHydrocortisone 1%
Active ingredientHYDROCORTISONE
Label structure14 sections

Indications and uses

For temporary relief of itching associated with minor skin irritations and rashes ● external feminine, genital 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 the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use and ask a doctor. For External and anal itching in adults: When practical, clean 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 For External anal and genital itching...

Storage and handling

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F) Tamper evident, do not use if packet is torn, cut or opened. Avoid excessive heat and humidity.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

INDICATIONS & USAGE SECTION

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

● external feminine, genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Do Not Use

OTC - DO NOT USE SECTION

  • For the treatment of diaper rash, consult a doctor.
  • With any other Hydrocortisone product unless you have consulted a doctor
  • If you have a vaginal discharge, consult a doctor

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid Contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop using this product and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product.
  • Rectal bleeding occurs

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use and ask a doctor.

For External and anal itching in adults:

When practical, clean 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

For External anal and genital itching in children under 12 years of age:

Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzoic Acid, Chlorphenesin, citric acid, glycerin, glycerol monostearate, methylparaben, mineral oil, petrolatum, Phenoxyethanol, Polysorbate 80, purified water, titanium dioxide, trisodium citrate

Other information

STORAGE AND HANDLING SECTION

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Tamper evident, do not use if packet is torn, cut or opened.

Avoid excessive heat and humidity.

SPL UNCLASSIFIED SECTION

Distributed by:

Trifecta Pharmaceuticals USA™

Ft. Lauderdale, FL 33301 USA

Online: www.trifecta-pharma.com

Reorder No. 1016SL

To reorder call: 1-888-296-9067

Fax: 888-878-3609

Questions

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hydrocortisone-cream-09ghydrocortisone-cream-09g

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-06969396-069-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
MINERAL OILT5L8T28FGPIACT
BENZOIC ACID8SKN0B0MIMIACT
CHLORPHENESINI670DAL4SZIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
HYDROCORTISONEWI4X0X7BPJACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
ffc1465a-4d96-96f3-e053-6294a90af88bb478c1c7-6fb8-4a55-e053-2a95a90a360a2023-07-05WarningsExact identifier
spl set id: b478c1c7-6fb8-4a55-e053-2a95a90a360a

Reported adverse events (FAERS/openFDA)#

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