61010-5800,Safetec First Aid 1% Hydrocortisone Cream

Manufacturer
Safetec of America, Inc.
Effective date
2026-08-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-18 02:01:59

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure12 sections

Indications and uses

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

Dosage and administration

for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily 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 blotting with toilet tissue or a soft cloth before app...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not usefor the treatment of diaper rash
  • in eyes
  • for feminine itching
  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with any other Hydrocortisone product unless you have consulted a doctor

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

  • for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
  • 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 blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age: for external anal itching, consult a doctor

Other information:

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

Questions or Comments? 1-800-456-7077

OTC - QUESTIONS SECTION

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 . 800-456-7077
www.safetec.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

Safetec

1% Hydrocortisone Cream™

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label
PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

PRINCIPAL DISPLAY PANEL – Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5800-2

Safetec

First Aid

1% Hydrocortisone Cream

For Temporary Relief of

Itching Associated with

Minor Skin Irritations,

Inflammation, or Rashes

Reorder no. 53110

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

PRINCIPAL DISPLAY PANEL – Box Label
PRINCIPAL DISPLAY PANEL – Box Label

PRINCIPAL DISPLAY PANEL – 10 Packet Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec®

FIRST AID

Hydrocortisone Cream

1% Hydrocortisone for relief from itching,
inflammation, and rashes

10 Packets

Each Packet Net Wt. 0.9g

Made in USA

Reorder no. 53108

PRINCIPAL DISPLAY PANEL – 10 Packet Box Label
PRINCIPAL DISPLAY PANEL – 10 Packet Box Label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-5800-22024-02-13C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-22024-02-13C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-02-13C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-02-13C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-02-13C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-02-13C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-22024-01-30C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-22024-01-30C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-01-30C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-01-30C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-01-30C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-01-30C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJ1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJ1
alcoholINACTIVE INGREDIENT3K9958V90M1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1S1
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
mineral oilINACTIVE INGREDIENTT5L8T28FGP1
paraffinINACTIVE INGREDIENTI9O0E3H2ZE1
PEG-150 distearateINACTIVE INGREDIENT6F36Q0I0AC1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4M1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
steareth-20INACTIVE INGREDIENTL0Q8IK9E081
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
61010-580061010-5800-1, 61010-5800-3, 61010-5800-2, 61010-5800-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-02-07full-release2026-06-01 00:08:36

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 · 95 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
55 equally ranked IID candidates
steareth-20STEARETH-20L0Q8IK9E08CREAM / TOPICAL4.15 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
55 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
55 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
55 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
55 equally ranked IID candidates
steareth-20STEARETH-20L0Q8IK9E08CREAM / TOPICAL4.15 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
steareth-20STEARETH-20L0Q8IK9E08CREAM / TOPICAL4.15 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
steareth-20STEARETH-20L0Q8IK9E08CREAM / TOPICAL4.15 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
55 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
55 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
55 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
55 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
55 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
55 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
55 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
55 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
5 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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KrogerHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATEKroger5905a7b2-36b8-9da7-e063-6394a90a28cd2026-08-14WarningsExact identifier
ndc (package): 61010-5800-1
ndc11 (package): 61010580001
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
ndc (package): 61010-5800-2
ndc (package): 61010-5800-4
ndc (package): 61010-5800-1
ndc (package): 61010-5800-3
ndc (product): 61010-5800
ndc11 (package): 61010580001
ndc11 (package): 61010580002
ndc11 (package): 61010580004
ndc11 (package): 61010580003
spl id: 58f3ba80-d594-c121-e063-6294a90a5e2e
spl set id: da2b3b2c-11e0-401b-bbd2-d019271d1b3d
WalgreensDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLWalgreen Co.5630f48b-404c-b847-e063-6394a90a8d8e2026-07-09WarningsExact identifier
ndc (package): 61010-5800-1
ndc11 (package): 61010580001
Care ScienceDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLASO LLC562f2b2c-d234-e491-e063-6294a90a705f2026-07-08WarningsExact identifier
ndc (package): 61010-5800-1
ndc11 (package): 61010580001

Reported adverse events (FAERS/openFDA)#

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