Active ingredient

Manufacturer
Marie's Original Formulas, LLC | QCR Enterprises LLC | Marie's Original Formulas LLC
Effective date
2026-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-17 21:45:30

Label at a glance#

ProductMarie Originals Medicated Outdoor Anti Itch
Active ingredientHYDROCORTISONE
Label structure15 sections

Indications and uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and seborrheic dermatitis.

Dosage and administration

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: ask a doctor

Storage and handling

Store at 20° to 25°C (68° to 77°F). Protect from excessive heat and direct sunlight. Keep container tightly closed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

BackBack

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

for the treatment of diaper rash. Consult a doctor.

if you have a skin infection in the affected area unless directed by a doctor.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

condition covers a large area of the body

symptoms persist or worsen

you have signs of skin infection

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

do not use more than directed

do not bandage or cover treated skin unless directed by a doctor

Stop use and ask a doctor

OTC - STOP USE SECTION

condition worsens

symptoms last more than 7 days

symptoms clear up and occur again within a few days

redness, irritation, or infection develops

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 of age and older: apply to affected area not more than 3 to 4 times daily

children under 2 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 20, Calendula Officinalis Flower Extract, Panthenol, Saccharide Isomerate, Hamamelis Virginiana (Witch Hazel) Water, Bisabolol, Sodium Phytate.

Other information

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F).

Protect from excessive heat and direct sunlight.

Keep container tightly closed.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-48-MARIE

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Marie Originals

Medicated Outdoor

ANTI-ITCH SPRAY

HYDROCORTISONE 1%

Poison Ivy/Oak Relief

Skin Rash Relief

Insect Bite Relief

Fast-Acting Relief for Skin Irritation

• Temporarily Relieves Itching
• Fast-Drying, Easy-to-Apply Spray
• Soothes Redness, Sensitivity & Skin Discomfort

NET CONTENTS 6 FL OZ (177 mL)

FrontFront

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850073386552GTIN-13: 0850073386552
EAN-13: 0850073386552
GTIN-12: 850073386552
UPC-A: 850073386552
GTIN storage (14 digits): 00850073386552
Anti Itch Spray - Label V3 3.jpg

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87541-03187541-031-63
87541-321

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas, LLC5517ee5f-1c51-cfd6-e063-6294a90af56f2026-06-25WarningsExact identifier
ndc (package): 87541-031-63
ndc (product): 87541-031
ndc11 (package): 87541003163
spl id: 5517ee5f-1c52-cfd6-e063-6294a90af56f
spl set id: 5517ee5f-1c51-cfd6-e063-6294a90af56f
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas LLC55188ede-68cd-fcc6-e063-6394a90a5c582026-06-25WarningsExact identifier
ndc (product): 87541-321

Reported adverse events (FAERS/openFDA)#

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