FDA.reportPublic FDA data

HYDROCORTISONE CREAM USP, 1%

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Effective date
2019-09-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:12:24

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE
Label structure11 sections

Label contents#

Full prescribing information#

Active Ingredient (in each gram):

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 10 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

  1. 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

  1. E. FOUGERA & CO.
    A division of Fougera Pharmaceuticals Inc., Melville, NY 11747
    W5159B
    R11/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0154-31

HYDROCORTISONE CREAM USP, 1%

  1. ANTI-ITCH CREAM
    MAXIMUM STRENGTH
    available without prescription

NET WT 28.35g (1 Oz)

tubelabel
tubelabel

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0154-31

HYDROCORTISONE CREAM USP, 1%

  1. ANTI-ITCH CREAM
    MAXIMUM STRENGTH
    available without prescription

NET WT 28.35g (1 Oz)

CARTON
CARTON

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0154-08GM - Gram0168-0154b3aeb74c-bb26-4575-ba8e-701e0ccbd31f12014-10-03
0168-0154-31GM - Gram0168-0154186635df-94e4-4c82-9db9-5923d8edb99812014-10-03

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
0168-01540168-0154-31, 0168-0154-08

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 ACID, UNSPECIFIED FORM33X04XA5ATIACT
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
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YPOWDER / ORAL0.11 mgExact identifier — unii candidate
12 equally ranked IID candidates
lactic acidLACTIC ACID33X04XA5ATSUPPOSITORY / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
lactic acidLACTIC ACID33X04XA5ATAEROSOL, FOAM / TOPICAL11 mgExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4SOLUTION / RECTAL6.67 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
isopropyl palmitateISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii candidate
8 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii candidate
19 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / TOPICAL2.15 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii candidate
11 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii candidate
11 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YCREAM / VAGINAL425 mgExact identifier — unii candidate
12 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii candidate
19 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact 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
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii candidate
50 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
isopropyl palmitateISOPROPYL PALMITATE8CRQ2TH63MFILM / TRANSDERMAL2 mgExact identifier — unii candidate
8 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
isopropyl palmitateISOPROPYL PALMITATE8CRQ2TH63MOINTMENT / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YOINTMENT / TOPICAL569 mgExact identifier — unii candidate
12 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
polyoxyl 40 stearatePOLYOXYL 40 STEARATE TYPE I13A4J4NH9ISPONGE / TOPICALNAExact identifier — unii candidate
13 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YTABLET / ORAL20 mgExact identifier — unii candidate
12 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XAEROSOL, FOAM / TOPICAL0.55 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 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
2cd1c568-66d8-4374-b6e9-ad286d855701d3586893-b705-4fa0-bf03-218da7db9aa42019-09-11WarningsExact identifier
spl id: 2cd1c568-66d8-4374-b6e9-ad286d855701
spl set id: d3586893-b705-4fa0-bf03-218da7db9aa4

Reported adverse events (FAERS/openFDA)#

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