Itch Fixer

Manufacturer
Welly Health PBC
Effective date
2021-02-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:34

Label at a glance#

ProductItch Fixer
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

For temporary relief of itching associated with minor skin irritations and rashes due to • eczema • insect bites • poison ivy • poison oak • poison sumac • soaps • detergents • cosmetics • jewelry • seborrheic dermatitis • psoriasis • external feminine, genital 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 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. For external anal itching • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product. • Children under 12 years with...

Storage and handling

Store at a controlled room temperature 68°–77°F (20°–25°C).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

For temporary relief of itching associated with minor skin irritations and rashes due to • eczema • insect bites • poison ivy • poison oak

• poison sumac • soaps • detergents • cosmetics • jewelry • seborrheic dermatitis • psoriasis • external feminine, genital 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: • for the treatment of diaper rash • for external genital itching – if you have a vaginal discharge, consult a doctor.

When using this product • avoid contact with eyes • do not begin the use of any other hydrocortisone product unless

you have consulted a doctor • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed

by a  doctor. In case  of  bleeding, stop use, consult a doctor • do not put this product into the rectum by using fingers or any mechanical device or

applicator.

Stop use and ask a doctor if • condition worsens • If symptoms persist for more than 7 days or clear up and reoccur, discontinue use of

this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

• Do not use if pregnant or breastfeeding.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years 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. For external anal itching

• Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet

tissue or a soft cloth before application of this product.

• Children under 12 years with external anal itching: consult a doctor.

Other information 

STORAGE AND HANDLING SECTION

Store at a controlled room temperature 68°–77°F (20°–25°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Aloe Vera Oil, Benzoic Acid, Cetostearyl Alcohol, Glyceryl Stearate, Jojoba Oil, Polysorbate 80, Oleyl Alcohol, Sorbic Acid, Sorbitan Monooleate

SPL UNCLASSIFIED SECTION

1% Hydrocortisone Anti-Itch Cream

FREE FROM

      x

Petrolatum

Parabens

Sulfates

Mineral Oil

Fragrance

FRAGRANCE FREE

KID FRIENDLY

MADE WITH SQUEAKY CLEAN INGREDIENTS FOR HAPPY HEALING

SQUEAKY CLEAN FIRST AID

Formulated with naturally derived plant-based ingredients

ALOE VERA known to help soothe skin

JOJOBA OIL known to help moisturize skin

HELPS PROVIDE TEMPORARY ITCH RELIEF FROM

skin irritation

rashes

insect bites 

poison ivy

eczema

Packaging is recyclable.

Distributed by Welly Health PBC

Minneapolis, MN 55402

1-833-BE-WELLY | getwelly.com

Product of USA and Canada with globally sourced materials.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN2
106258hydrocortisone 10 MG/ML Topical CreamSCD2
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY2
106258hydrocortisone 1 % Topical CreamSY2
106258hydrocortisone 1 GM per 100 GM Topical CreamSY2

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
72663-493-662025-01-30C16284748780-12cef2736-8a1f-d83d-e063-dadaa90ab31fItch Fixer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72663-493-66Itch Fixer57 g in 1 TUBECREAM572
72663-493-66Itch Fixer1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72663-493ITCH FIXER (HYDROCORTISONE) CREAM [WELLY HEALTH PBC]2Legacy NDC, 2 package rows20211002_e0d12acd-6e99-417d-a983-231e13bc1dd2.zip

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
72663-49372663-493-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
ccecee2e-8dc5-4d0a-9bbe-a38da57be80ee0d12acd-6e99-417d-a983-231e13bc1dd22021-02-25WarningsExact identifier
spl id: ccecee2e-8dc5-4d0a-9bbe-a38da57be80e
spl set id: e0d12acd-6e99-417d-a983-231e13bc1dd2

Reported adverse events (FAERS/openFDA)#

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