FDA.reportPublic FDA data

Western Family

Manufacturer
Western Family Foods Inc | Taro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceuticals Inc.
Effective date
2013-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:34:53

Label at a glance#

ProductWestern Family HydroCortisone Plus 12 Moisturizers
Active ingredientHydrocortisone
Label structure11 sections

Indications and uses

temporary relief of itching associated with minor skin irritations and rashes due to eczema insect bites poison ivy, poison oak, or poison sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis external 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 affected area not more than 3 to 4 times daily Children under 2 years of age: do not use. consult a doctor 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 a soft cloth before application of this product Children under 12 years of age: consult a doctor

Storage and handling

To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube store at room temperature see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch cream

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a vaginal discharge
  • rectal bleeding
  • diaper rash

OTC - WHEN USING SECTION

When using this product consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 to 4 times daily

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

For external anal itching

SPL UNCLASSIFIED SECTION

  • 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 a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed By:
Western Family Foods, Inc.
P.O. Box 4057, Portland, OR 97208

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HydroCortisone
1% Hydrocortisone Anti-Itch CREAM PLUS
12 MOISTURIZERS

NET WT 1 OZ (28g)
MAXIMUM STRENGTH

Principal Display Panel - 28 g Tube Carton
Principal Display Panel - 28 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN1
106258hydrocortisone 10 MG/ML Topical CreamSCD1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY1
106258hydrocortisone 1 % Topical CreamSY1
106258hydrocortisone 1 GM per 100 GM Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55312-063-022020-01-31C16284748780-19d75b9d0-5be4-f424-e053-dadaa90a57ceWestern Family ® HydroCortisone Plus 12 Moisturizers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55312-063-02Western Family HydroCortisone Plus 12 Moisturizers28 g in 1 TUBECREAM281
55312-063-02Western Family HydroCortisone Plus 12 Moisturizers1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-063WESTERN FAMILY HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [WESTERN FAMILY FOODS INC]1Legacy NDC, 2 package rows20130318_45be083c-5330-4526-8378-db67243408c6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJ1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJ1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1S1
chamomile flower oilINACTIVE INGREDIENT60F80Z61A91
cholecalciferolINACTIVE INGREDIENT1C6V77QF411
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QP1
corn oilINACTIVE INGREDIENT8470G57WFM1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE41
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63M1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2D1
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
mineral oilINACTIVE INGREDIENTT5L8T28FGP1
paraffinINACTIVE INGREDIENTI9O0E3H2ZE1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4B1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141J1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1Y1
Vitamin A palmitateINACTIVE INGREDIENT1D1K0N0VVC1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55312-06355312-063-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
HydrocortisoneWI4X0X7BPJACTIB
cetostearyl alcohol2DMT128M1SIACT
sodium lauryl sulfate368GB5141JIACT
sodium cetostearyl sulfate7ZBS06BH4BIACT
chamomile flower oil60F80Z61A9IACT
citric acid monohydrate2968PHW8QPIACT
corn oil8470G57WFMIACT
glycerinPDC6A3C0OXIACT
glyceryl monostearate230OU9XXE4IACT
isopropyl palmitate8CRQ2TH63MIACT
maltodextrin7CVR7L4A2DIACT
methylparabenA2I8C7HI9TIACT
mineral oilT5L8T28FGPIACT
paraffinI9O0E3H2ZEIACT
petrolatum4T6H12BN9UIACT
propylene glycol6DC9Q167V3IACT
propylparabenZ8IX2SC1OHIACT
water059QF0KO0RIACT
stearyl alcohol2KR89I4H1YIACT
Vitamin A palmitate1D1K0N0VVCIACT
cholecalciferol1C6V77QF41IACT
.alpha.-tocopherol acetate9E8X80D2L0IACT

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 10 · 572 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii candidate
9 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii candidate
11 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
42 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
15 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JSUSPENSION / ORAL705 mgExact identifier — unii candidate
42 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JPOWDER / VAGINAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
isopropyl palmitateISOPROPYL PALMITATE8CRQ2TH63MAEROSOL, SPRAY / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JGEL / VAGINAL0.2 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHJELLY / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii candidate
42 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii candidate
79 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZESOAP / TOPICAL0.4 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / NASAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECAPSULE, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 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
487d7e98-cead-45d5-b338-9df3d93e2e9645be083c-5330-4526-8378-db67243408c62013-03-14WarningsExact identifier
spl id: 487d7e98-cead-45d5-b338-9df3d93e2e96
spl set id: 45be083c-5330-4526-8378-db67243408c6

Reported adverse events (FAERS/openFDA)#

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