FDA.reportPublic FDA data

Green Guard Maximum Strength Hydrocortisone Cream 1%

Manufacturer
Unifirst First Aid Corporation
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:12:56

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Hydrocortisone 1.0%

OTC - PURPOSE SECTION

Purpose

Anti itch

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or lasts more than 7 days, or clears and occurs again within a few days
  • you begin use of any other Hydrocortisone product unless you have consulted a doctor
  • bleeding occurs

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • for adults and children (2 years of age and older): apply to affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or botting with toilet tissue or a soft cloth before application of this product

OTHER SAFETY INFORMATION

Other information

  • store at room temperature (do not freeze)
  • tamper evident, do not use any opened or torn packets

OTC - QUESTIONS SECTION

Questions or comments?

1-800-869-6970

INACTIVE INGREDIENT SECTION

Inactive ingredient

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Green Guard Hydrocortisone Label

Maximum Strength

Hydrocortisone
cream 1%

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

Green Guard

Order # 3103

25 Per Box

Net Wt 0.9 g (1/32 oz) Packets

31033103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN14
106258hydrocortisone 10 MG/ML Topical CreamSCD14
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY14
106258hydrocortisone 1 % Topical CreamSY14
106258hydrocortisone 1 GM per 100 GM Topical CreamSY14

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-397-12Hydrocortisone10 in 1 BOXCREAM1014
47682-397-12Hydrocortisone0.9 g in 1 PACKETCREAM0.914
47682-397-35Hydrocortisone144 in 1 BAGCREAM14414
47682-397-35Hydrocortisone0.9 g in 1 PACKETCREAM0.914
47682-397-71Hydrocortisone0.9 g in 1 PACKETCREAM0.914
47682-397-71Hydrocortisone20 in 1 BOXCREAM2014
47682-397-73Hydrocortisone25 in 1 BOXCREAM2514
47682-397-99Hydrocortisone0.9 g in 1 PACKETCREAM0.914

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJ3
HydrocortisoneACTIVE MOIETYWI4X0X7BPJ3
alcoholINACTIVE INGREDIENT3K9958V90M3
methylparabenINACTIVE INGREDIENTA2I8C7HI9T3
mineral oilINACTIVE INGREDIENTT5L8T28FGP3
paraffinINACTIVE INGREDIENTI9O0E3H2ZE3
petrolatumINACTIVE INGREDIENT4T6H12BN9U3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH3
waterINACTIVE INGREDIENT059QF0KO0R3
white waxINACTIVE INGREDIENT7G1J5DA97F3

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
47682-39747682-397-71, 47682-397-12, 47682-397-99, 47682-397-73, 47682-397-35

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
ALCOHOL3K9958V90MIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
WHITE WAX7G1J5DA97FIACT
HYDROCORTISONEWI4X0X7BPJACTIB

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 2 · 102 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
66 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
66 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
66 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
66 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
66 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
66 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
66 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
66 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
66 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
66 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
66 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
66 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
6 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
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation69d6645e-db3c-4dc0-a9a5-e2bc963e2f282025-09-08WarningsExact identifier
ndc (package): 47682-397-73
ndc (package): 47682-397-12
ndc (package): 47682-397-99
ndc (package): 47682-397-35
ndc (package): 47682-397-71
ndc (product): 47682-397
ndc11 (package): 47682039712
ndc11 (package): 47682039771
ndc11 (package): 47682039799
ndc11 (package): 47682039773
ndc11 (package): 47682039735
spl id: 3e4ef6bb-27cd-4a16-e063-6394a90a1e03
spl set id: 69d6645e-db3c-4dc0-a9a5-e2bc963e2f28

Reported adverse events (FAERS/openFDA)#

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