Weeks and Leo Anti-itch

Manufacturer
weeks & Leo, Inc. | Weeks & Leo | Weeks & Leo Co., Inc.
Effective date
2020-11-24
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:05:45

Label at a glance#

ProductWeeks and Leo 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, methylparaben, mineral oil, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white wax

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Content of labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Armand.jpgArmand.jpgHydrocortisone Cream 1% with Aloe Vera

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
11383-26911383-269-51

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

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
d61cc62c-c25f-1446-e053-2995a90acb77853f7e92-7815-4023-e053-2991aa0a8db62022-01-21WarningsExact identifier
spl set id: 853f7e92-7815-4023-e053-2991aa0a8db6

Reported adverse events (FAERS/openFDA)#

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