FDA.reportPublic FDA data

HYDROCORTISONE CREAM USP, 0.5%

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Effective date
2012-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:46:39

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE
Label structure11 sections

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 5 mg

Purpose:

OTC - PURPOSE SECTION

Anti-itch

INDICATIONS & USAGE SECTION

Uses:

  • for temporary relief of itching associated with minor skin irritations and rashes due to:
  • eczema
  • insect bites
  • soaps and detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • poison ivy , oak or sumac
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor

WARNINGS SECTION

Warnings:

For external use only

Do not use

  • in children under 2 years of age
  • if you have a vaginal discharge
  • for the treatment of diaper rash

Ask a doctor before use if you have

  • external genital or feminine itching
  • external anal itching
  • bleeding

When using this product

  • avoid contact with 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 use and ask a doctor

  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and do not begin use of any other hydrocortisone product

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.

DOSAGE & ADMINISTRATION SECTION

Directions:

For minor skin irritations and rashes,

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

For external anal 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 soft cloth before application of this product
  • children: under 12 years of age, consult a doctor.

SPL UNCLASSIFIED SECTION

Other information:

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
  • store at room temperature
  • see crimp of tube for Lot Number and Expiration Date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, glycerin, glyceryl monostearate, isopropyl palmitate, lactic acid, paraffin, polyoxyl 40 stearate, potassium sorbate, purified water, sorbitan monostearate and stearyl alcohol.

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

W5156B

R11/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0014-31

HYDROCORTISONE CREAM USP, 0.5%

ANTI-ITCH CREAM

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0014-31

HYDROCORTISONE CREAM USP, 0.5%

ANTI-ITCH CREAM

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0014-312022-03-25C16284748780-19d75b9d0-13cc-f424-e053-dadaa90a57ceHYDROCORTISONE CREAM USP, 0.5%
0168-0014-312020-01-31C16284748780-19d75b9d0-13cc-f424-e053-dadaa90a57ceHYDROCORTISONE CREAM USP, 0.5%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0014-31GM - Gram0168-00144f690f63-4539-49de-b89f-5f948f97297812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJ1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBH1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE41
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63M1
lactic acidINACTIVE INGREDIENT33X04XA5AT1
paraffinINACTIVE INGREDIENTI9O0E3H2ZE1
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9I1
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ41
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58X1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1Y1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0168-00140168-0014-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
benzyl alcoholLKG8494WBHIACT
glycerinPDC6A3C0OXIACT
glyceryl monostearate230OU9XXE4IACT
isopropyl palmitate8CRQ2TH63MIACT
lactic acid33X04XA5ATIACT
paraffinI9O0E3H2ZEIACT
polyoxyl 40 stearate13A4J4NH9IIACT
potassium sorbate1VPU26JZZ4IACT
water059QF0KO0RIACT
sorbitan monostearateNVZ4I0H58XIACT
stearyl alcohol2KR89I4H1YIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 238 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YAEROSOL, FOAM / TOPICAL37 mgExact identifier — unii candidate
12 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XAEROSOL, FOAM / TOPICAL0.55 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAVENOUS400 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZEAEROSOL, FOAM / TOPICAL14235 mgExact identifier — unii candidate
11 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
polyoxyl 40 stearatePOLYOXYL 40 STEARATE TYPE I13A4J4NH9ITABLET / ORAL8.48 mgExact identifier — unii candidate
13 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSUPPOSITORY / VAGINALNAExact identifier — unii candidate
11 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
lactic acidLACTIC ACID33X04XA5ATCREAM / TOPICAL1 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
lactic acidLACTIC ACID33X04XA5ATINJECTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
18 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
isopropyl palmitateISOPROPYL PALMITATE8CRQ2TH63MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
polyoxyl 40 stearatePOLYOXYL 40 STEARATE TYPE I13A4J4NH9ICAPSULE / ORAL14 mgExact identifier — unii candidate
13 equally ranked IID candidates
isopropyl palmitateISOPROPYL PALMITATE8CRQ2TH63MGEL / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZESOAP / TOPICAL0.4 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
lactic acidLACTIC ACID33X04XA5ATSUPPOSITORY / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSOLUTION / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / SOFT TISSUE40 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
lactic acidLACTIC ACID33X04XA5ATINJECTION / INTRACARDIAC0.01 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
polyoxyl 40 stearatePOLYOXYL 40 STEARATE TYPE I13A4J4NH9ILOTION / TOPICAL3 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
polyoxyl 40 stearatePOLYOXYL 40 STEARATE TYPE I13A4J4NH9ISOLUTION / OPHTHALMIC7 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / RECTAL129 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii candidate
11 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XLOTION / TOPICAL89 mgExact identifier — unii candidate
11 equally ranked IID candidates
lactic acidLACTIC ACID33X04XA5ATGEL / TOPICAL30 mgExact identifier — unii candidate
18 equally ranked IID candidates
polyoxyl 40 stearatePOLYOXYL 40 STEARATE TYPE I13A4J4NH9IGRANULE / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
lactic acidLACTIC ACID33X04XA5ATCONCENTRATE / ORAL50 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates

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
a9f6cac9-0f75-4d8a-8bf3-1ddb23609653b600a0ef-104e-4051-9e48-9022eed5a7d92019-09-11WarningsExact identifier
spl set id: b600a0ef-104e-4051-9e48-9022eed5a7d9

Reported adverse events (FAERS/openFDA)#

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