OHL O2

Manufacturer
AMAROS CO., LTD.
Effective date
2019-04-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:08

Label at a glance#

ProductOHL O2
Active ingredientAllantoin
Label structure8 sections

Indications and uses

Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening after washing face.

Dosage and administration

Dosage and Administration: The above product can be applied at any time when feel dryness, just spray several times the mist over face and feel the freshness. This product contains over than 20 kinds of Oriental Herbal Extracts. Keep moisture of the skin, calming and improve tone of the skin.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Allantoin 0.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Butylene Glycol, Sodium PCA, Alcohol Denat., Sodium Hyaluronate, Sodium Citrate, Portulaca Oleracea Extract, Glycine Soja (Soybean) Seed Extract, Anthemis Nobilis Flower/Leaf Extract, Morus Alba Bark Extract, PEG-60 Hydrogenated Castor Oil, Hydrolyzed Collagen, Tocopheryl Acetate, Caprylyl Glycol, Caprylhydroxamic Acid, Citrus Paradisi (Grapefruit) Fruit Extract, Centella Asiatica Extract, Lavandula Angustifolia (Lavender) Oil, Hamamelis Virginiana (Witch Hazel) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Disodium EDTA, Spirulina Maxima Extract, Piper Methysticum Leaf/Root/Stem Extract, Lavandula Angustifolia (Lavender) Extract, Human Oligopeptide-1, Copper Tripeptide-1, Ceramide 3.

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: 1. In case of having following symptoms after using this product, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: Keep out of reach of babies and children.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening after washing face.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration: The above product can be applied at any time when feel dryness, just spray several times the mist over face and feel the freshness. This product contains over than 20 kinds of Oriental Herbal Extracts. Keep moisture of the skin, calming and improve tone of the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60899-040-012022-01-28C16284748780-1d6a99b39-5038-a426-e053-dadaa90af4c22fff78fb-6fb9-47a2-85de-8c6f4d444d2a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60899-040-01OHL O260 mL in 1 CARTONSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60899-040OHL O2 (ALLANTOIN) SPRAY [AMAROS CO., LTD.]2Legacy NDC, 1 package rows20190411_2fff78fb-6fb9-47a2-85de-8c6f4d444d2a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AllantoinACTIVE INGREDIENT344S277G0Z1
ALLANTOINACTIVE MOIETY344S277G0Z1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60899-04060899-040-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Allantoin344S277G0ZACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
50d23c79-d69e-4dc8-9f12-8313886a09ab2fff78fb-6fb9-47a2-85de-8c6f4d444d2a2019-04-11WarningsExact identifier
spl id: 50d23c79-d69e-4dc8-9f12-8313886a09ab
spl set id: 2fff78fb-6fb9-47a2-85de-8c6f4d444d2a

Reported adverse events (FAERS/openFDA)#

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