FDA.reportPublic FDA data

MediORO Signature Essence Mist

Manufacturer
MEDIFUN Inc.
Effective date
2022-06-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:57

Label at a glance#

ProductMediORO Signature Essence Mist
Active ingredientOLIVE OIL
Label structure10 sections

Indications and uses

■ Antimicrobial and anti-inflammatory effects help. ■ Helps with skin care and skin protection. ■ It helps to moisturize your skin.

Dosage and administration

■ Spray lightly about 10cm away from the area of use. ■ You can use if from time to time if necessary. ■ It helps when your skin is dry.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Olive oil 1.0%

PURPOSE

OTC - PURPOSE SECTION

Antibacterial, Odor care, Calming the skin

Uses

INDICATIONS & USAGE SECTION

■ Antimicrobial and anti-inflammatory effects help.
■ Helps with skin care and skin protection.
■ It helps to moisturize your skin.

WARNINGS

WARNINGS SECTION

If the area of use has abnormal symptoms or side effects such as red spots, swelling, or iching, consult a specialist.
Do not use it in areas with wounds.
Do not spray around the eyes, mucous membranes,etc.
Keep out of reach of children
Keep away from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

■ Spray lightly about 10cm away from the area of use.
■ You can use if from time to time if necessary.
■ It helps when your skin is dry.

Other Information

OTHER SAFETY INFORMATION

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light
■ Keep out of reach of children.

Questions

OTC - QUESTIONS SECTION

■ www.medioro.shop / +82) 0507-1390-9493 / medifun35600@gmail.com

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Dipropylene Glycol, PEG-60 Hydrogenated Castor Oil, Glycerin, Aloe Vera Leaf Extract, Methylpropanediol, Rosa Damascena Extract, PEG-100 Stearate, Polysorbate 80, Glyceryl Stearate, Thuja Occidentalis Leaf Oil, Chamaecyparis Obtusa Leaf Extract, Sodium PCA, Scutellaria Baicalensis Root Extract, Mentha Piperita(Peppermint) Oil, Portulaca Oleracea Extract, Dimethyl Sulfone, Allantoin, Origanum Vulgare Leaf Extract, Cinnamomum Cassia Bark Extract, Salix Alba(Willow) Bark Extract, Panthenol, Lactobacillus/Soybean Ferment Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OLIVE OIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82363-020-022024-01-30C16284748780-11030e365-3cd8-111a-e063-dadaa90a10e2c0b843a8-9eb2-4eac-b638-4a1e874ef768

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82363-020-01MediORO Signature Essence Mist160 mL in 1 BOTTLE, SPRAYSPRAY1603
82363-020-02MediORO Signature Essence Mist1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82363-020MEDIORO SIGNATURE ESSENCE MIST (OLIVE OI L) SPRAY [MEDIFUN INC.]3Legacy NDC, 2 package rows20220626_c0b843a8-9eb2-4eac-b638-4a1e874ef768.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82363-02082363-020-01, 82363-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EACTIB
Water059QF0KO0RIACT
Dipropylene GlycolE107L85C40IACT
PEG-60 Hydrogenated Castor Oil02NG325BQGIACT

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
00dfc976-4974-46eb-b5e5-9649b53562cfc0b843a8-9eb2-4eac-b638-4a1e874ef7682022-06-23WarningsExact identifier
spl id: 00dfc976-4974-46eb-b5e5-9649b53562cf
spl set id: c0b843a8-9eb2-4eac-b638-4a1e874ef768

Reported adverse events (FAERS/openFDA)#

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