FDA.reportPublic FDA data

Green Guard Maximum Strength Hydrocortisone Cream 1%

Manufacturer
Unifirst First Aid Corporation
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:07:30

Label at a glance#

ProductGreen Guard Hydrocortisone 1%
Active ingredientHYDROCORTISONE ACETATE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1 %)

OTC - PURPOSE SECTION

Purpose

Anti-itch cream

INDICATIONS & USAGE SECTION

Uses

  • for the temporary relief of itching associated with minor skin irritations and rashes
  • 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. Consult a doctor.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you've consulted a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

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

  • 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: do not use, consult a doctor

OTHER SAFETY INFORMATION

Other information

  • clean the affected area
  • store at room temperature (do not freeze)
  • tamper evident. Do not use any opened or torn packets
  • you may report a serious adverse reaction to this product to 800-634-7680

INACTIVE INGREDIENT SECTION

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

OTC - QUESTIONS SECTION

Questions or comments? 1-800-869-6970

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength

Hydrocortisone cream 1%

Temporary relief of itching associated with minor skin irritations and rashes

Green Guard

Order #3101

0.9 g packets 25 per box

31033103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN4
106258hydrocortisone 10 MG/ML Topical CreamSCD4
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY4
106258hydrocortisone 1 % Topical CreamSY4
106258hydrocortisone 1 GM per 100 GM Topical CreamSY4

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
47682-398-73Green Guard Hydrocortisone 1%0.9 g in 1 PACKETCREAM0.94
47682-398-73Green Guard Hydrocortisone 1%25 in 1 BOXCREAM254
47682-398-99Green Guard Hydrocortisone 1%0.9 g in 1 PACKETCREAM0.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-398GREEN GUARD HYDROCORTISONE 1% (HYDROCORTISONE) CREAM [UNIFIRST FIRST AID CORPORATION]4Current NDC, Legacy NDC, 3 package rows20240118_bd348e2a-57b1-3f17-e053-2a95a90a8bdc.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47682-39847682-398-73, 47682-398-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROCORTISONE ACETATE3X7931PO74ACTIB
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
MINERAL OILT5L8T28FGPIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

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
Green Guard Hydrocortisone 1%HYDROCORTISONEUnifirst First Aid Corporationbd348e2a-57b1-3f17-e053-2a95a90a8bdc2024-01-17WarningsExact identifier
ndc (package): 47682-398-99
ndc (package): 47682-398-73
ndc (product): 47682-398
ndc11 (package): 47682039873
ndc11 (package): 47682039899
spl id: 0f27fd55-d58c-63a1-e063-6394a90a62eb
spl set id: bd348e2a-57b1-3f17-e053-2a95a90a8bdc

Reported adverse events (FAERS/openFDA)#

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