1% Hydrocortisone Cream

Manufacturer
Afassco Inc.
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:53:14

Label at a glance#

ProductAFASSCO 1% Hydrocortisone
Active ingredientHYDROCORTISONE
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Hydrocorticone Cream 1%

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (In Each Gram)

Hydrocortisone 1%

OTC - PURPOSE SECTION

Purpose 

Anti-itch

INDICATIONS & USAGE SECTION

Uses:

  • for the temporary temporarily 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, and psoriasis scrapes
  • 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 - ASK DOCTOR SECTION

Consult a doctor:

  • before use if you have a vaginal discharge (for external feminine itching)
  • for external itching, do not exceed the recommended daily dosage or if bleeding occurs
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again in a few days
  • ask a doctor before use if you are using any other hydrocortisone product

OTC - WHEN USING SECTION

When using this product:

  • avoid contacty with eyes
  • do not put this produce into rectum by using fingers or any mechanical device or applicator

OTC - DO NOT USE SECTION

Do not use:

  • with 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 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 not more than 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 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 soft cloth before application of this product
• Children under 12 years of age; for external itching, consult a doctor

OTHER SAFETY INFORMATION

Other Information:

  • Store at controlled room temperature 15° to 30° C (59° to 86° F)
  • Tamper evident.  Do not use if packet is torn, cut, or opened.
  • Avoid excessive heat and humidity

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin,

Ceteareth-20, Isopropyl Myristate,

EDTA-2NA, Phenoxyethanol,

Tocopheryl Acetate,

Aloe Barbadensis Leaf Juice

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Afassco¦ ¦®

The First Choice
in First Aid

MAXIMUM STRENGTH
HYDROCORTISONE
PLUS MOISTURIZING ALOE

1% ANTI-ITCH ANALGESIC • FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                                25 ct.

Afassco¦ ¦®

The First Choice in First Aid

REMOVE TOP FOR EASY ACCESS

Compare To

Hydrocortisone

MAXIMUM STRENGTH
HYDROCORTISONE

1% ANTI-ITCH ANALGESIC • FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                    25 ct.

Afassco¦ ¦®

The First Choice in First Aid

MAXIMUM STRENGTH
HYDROCORTISONE

1% Crema de Fydrocortisona

instructiones: Para Adultos y ninos

2 anos y mas viejo.  Los ninos bajo

2 anos, consultan un medico para

picar anal externo.  Limpia el areaa

afectada con jabon y aclarado

aplique el producto.

1% ANTI-ITCH ANALGESIC • FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                      25 ct.

Afassco¦ ¦®

The First Choice in First Aid

Manufactured for Afassco, Inc. Minden, NV 89423

6   70254   60812   5

↓25 ct. Box↓

Hydrocrtson 608 25ctHydrocrtson 608 25ct

↓6 ct. Box↓

Hydrocrtson 380 6ctHydrocrtson 380 6ct

↓Unit Dose Package Label↓

Afassco¦ ¦®

The First Choice in First Aid

1% Hydrocortisone

Cream

Manufactured for Afassco

Minden, NV 89423

1gm (1/32 oz)

 Made in China

Hydrocort pouchHydrocort pouch

res

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51532-4608-12024-07-30C16284748780-11e7a6dab-1e74-a2ce-e063-dadaa90aadf71% Hydrocortisone Cream
51532-4608-22024-07-30C16284748780-11e7a6dab-1e74-a2ce-e063-dadaa90aadf71% Hydrocortisone Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51532-4608-1AFASSCO 1% Hydrocortisone25 in 1 BOXOINTMENT255
51532-4608-1AFASSCO 1% Hydrocortisone1 g in 1 POUCHOINTMENT15
51532-4608-2AFASSCO 1% Hydrocortisone6 in 1 BOXOINTMENT65
51532-4608-2AFASSCO 1% Hydrocortisone1 g in 1 POUCHOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51532-4608AFASSCO 1% HYDROCORTISONE (HYDROCORTISONE) OINTMENT [AFASSCO INC.]5Legacy NDC, 4 package rows20230113_9b8606c7-99f8-4019-b173-d4ab2e9d2d1a.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51532-460851532-4608-1, 51532-4608-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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
92af3a7d-2f36-4eff-81c0-3a9ed607527c9b8606c7-99f8-4019-b173-d4ab2e9d2d1a2023-01-12WarningsExact identifier
spl id: 92af3a7d-2f36-4eff-81c0-3a9ed607527c
spl set id: 9b8606c7-99f8-4019-b173-d4ab2e9d2d1a

Reported adverse events (FAERS/openFDA)#

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