Hydrocortisone Cream

Manufacturer
Moore Medical LLC
Effective date
2021-10-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:33:28

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes for external genital, feminine 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: ask a doctor For external and genital 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 beforeapplying Children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-itch)

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
  • for external genital, feminine 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

  • for the teatment of diaper rash
  • with any other Hydrocortisone product unless you have consulted a doctor
  • if you have vaginal discharge, consult a doctor

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and reappear again within a few days
  • rectal bleeding occurs

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 the affected area not more than 3 to 4 times daily

Children under 2 years of age:

ask a doctor

For external and genital 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 beforeapplying

Children under 2 years of age:

ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • store at room temperature 59° to 86° F (15° to 30º C)
  • tamper evident, do not use if packet is torn, cut or opened
  • avoid excessive heat and humidity

Inactive ingredients:

INACTIVE INGREDIENT SECTION

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-234-1464

Moore Medical Hydrocortisone Cream 1% Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mooremedical
Supporting Health & Care

Reorder No. 82464
UPN# 0-0607415-82464-3

MooreBrand®
Hydrocortisone
Cream 1%
144 Packets
Each Packet Net. Wt. 0.9gm

Temporary relief of itching
associated with minor skin irritation,
inflammation and rashes.

To reorder:
Call: 1.800.234.1464
Fax: 1.800.944.6667
Online:

www.mooremedical.com

Moore MedicalMoore Medical

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJ2
HydrocortisoneACTIVE MOIETYWI4X0X7BPJ2
alcoholINACTIVE INGREDIENT3K9958V90M2
methylparabenINACTIVE INGREDIENTA2I8C7HI9T2
mineral oilINACTIVE INGREDIENTT5L8T28FGP2
paraffinINACTIVE INGREDIENTI9O0E3H2ZE2
petrolatumINACTIVE INGREDIENT4T6H12BN9U2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH2
waterINACTIVE INGREDIENT059QF0KO0R2
white waxINACTIVE INGREDIENT7G1J5DA97F2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55670-80055670-800-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

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 5 · 280 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZETABLET, COATED / ORAL0.07 mgExact identifier — unii candidate
11 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHDROPS / NASAL14 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZEOINTMENT / RECTAL38 mgExact identifier — unii candidate
11 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SUSPENSION / ORAL8 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii candidate
68 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / PARENTERAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FSUPPOSITORY / RECTAL265 mgExact identifier — unii candidate
15 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZETABLET / ORAL0.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZESOAP / TOPICAL0.4 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR3.6 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii candidate
15 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FTABLET / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 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
ce291e69-b61e-18c2-e053-2a95a90a0af929b87306-0a9b-4ac9-84fa-ab120bd1cbac2021-10-12WarningsExact identifier
spl id: ce291e69-b61e-18c2-e053-2a95a90a0af9
spl set id: 29b87306-0a9b-4ac9-84fa-ab120bd1cbac

Reported adverse events (FAERS/openFDA)#

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