Otc - Active Ingredient
Hydrocortisone 1%
Marie Originals Medicated Outdoor Anti Itch Spray
FDA Label NDC 87541-321
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marie's Original Formulas Llc for the product Marie Originals Medicated Outdoor Anti Itch (NDC 87541-321). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
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.
Warnings
For external use only.
Do Not Use
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
condition covers a large area of the body
symptoms persist or worsen
you have signs of skin infection
When Using This Product
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 If
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
ask a health professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
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
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
Store at 20° to 25°C (68° to 77°F).
Protect from excessive heat and direct sunlight.
Keep container tightly closed.
Questions Or Comments?
Call 1-888-48-MARIE
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)
* Please review the disclaimer below.
