Quatriderm Anti-itch

Manufacturer
OPMX LLC | Weeks & Leo | Weeks & Leo Co., Inc.
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:03:28

Label at a glance#

ProductQuatriderm Anti-itch
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy, poison oak, and poison sumac cosmetics jewelry detergents soaps temporarily relieves external anal and genital 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 over: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor for external anal itching in adults: 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 applying. for exte...

Storage and handling

store at 20 °C to 25 °C (68 °F to 77 °F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1 %

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

eczema

seborrheic dermatitis

psoriasis

insect bites

poison ivy, poison oak, and poison sumac

cosmetics

jewelry

detergents

soaps

temporarily relieves external anal and genital itching

other uses of this product should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into the eyes

for external anal itching, do not use more than directed unless told to do so by a doctor

do not put into the rectum by using fingers or any mechanical device or applicator

Do not use

OTC - DO NOT USE SECTION

for the treatment of diaper rash. Ask a doctor.

for external genital itching if you have a vaginal discharge. Ask a doctor.

for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

Stop us and ask doctor if

OTC - STOP USE SECTION

condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

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

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

for external anal itching in adults:

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 applying.

for external anal itching in children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

aloe barbadensis (aloe vera) leaf juice, cetearyl alcohol, glycerin, light mineral oil, potassium sorbate, purified water, sodium benzoate, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white wax

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Content of labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelHydrocortisone Cream 1% with Aloe Vera

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN8
106258hydrocortisone 10 MG/ML Topical CreamSCD8
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY8
106258hydrocortisone 1 % Topical CreamSY8
106258hydrocortisone 1 GM per 100 GM Topical CreamSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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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
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705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
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fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-269-53Quatriderm Anti-itch1 in 1 CARTONCREAM18
69729-269-53Quatriderm Anti-itch56 g in 1 TUBECREAM568

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-269QUATRIDERM ANTI-ITCH (HYDROCORTISONE) CREAM [OPMX LLC]8Current NDC, Legacy NDC, 2 package rows20231207_83e59e10-9878-e5c2-e053-2a91aa0af25e.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-26969729-269-53

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 · 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
Quatriderm Anti-itchHYDROCORTISONEOPMX LLC83e59e10-9878-e5c2-e053-2a91aa0af25e2023-12-04WarningsExact identifier
ndc (package): 69729-269-53
ndc (product): 69729-269
ndc11 (package): 69729026953
spl id: 0bb8304b-0ea3-8c48-e063-6394a90a3a15
spl set id: 83e59e10-9878-e5c2-e053-2a91aa0af25e

Reported adverse events (FAERS/openFDA)#

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