FDA.reportPublic FDA data

AAPE Continuous Renewal Eye

Manufacturer
PROSTEMICS Co., Ltd. | Prostemics Co., Ltd. Factory
Effective date
2019-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:08

Label at a glance#

ProductAAPE Continuous Renewal Eye
Active ingredientNiacinamide, Adenosine
Label structure8 sections

Indications and uses

Uses: Helps brighten skin tone. Helps improve wrinkle problem.

Dosage and administration

Directions: Take proper amount and gently apply on to the face.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Niacinamide 2.00%, Adenosine 0.04%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Water, Human Adipocyte Conditioned Media Extract, Butylene Glycol, Glycerin, Limnanthes Alba (Meadowfoam) Seed Oil, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol, Glyceryl Stearate, Octyldodecyl Myristate, Helianthus Annuus (sunflower) Seed Oil, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone, BeesWax, PEG-100 Stearate, Stearic Acid, Caprylyl Glycol, Ethylhexylglycerin, Glyceryl Citrate/Lactate/Linoleate/Oleate, 1,2-Hexanediol, Olea Europaea (Olive) Fruit Oil, Polysorbate 60, Sodium Hyaluronate, Rubus Idaeus (Raspberry) Fruit Extract, Artemisia vulgaris extract, Hydrolyzed Extensin, Gentiana Lutea Root Extract, Achillea Millefolium Extract, Artemisia Absinthium Extract, Arnica Montana Flower Extract, Beta-Glucan, PEG-40 Hydrogenated Castor Oil, Tocopherol, PPG-26-Buteth-26, Acetyl Hexapeptide-8, Copper, Tripeptide-1, Fragrance

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Brightening, Anti wrinkle

WARNINGS

WARNINGS SECTION

Warnings:

For external use only
1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product
2. Do not apply to open wounds.
3. Avoid contact with eyes.
Storage and handling
4. Replace the cap after use
5. Keep out of reach of children.
6. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

Uses:

Helps brighten skin tone.

Helps improve wrinkle problem.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

Take proper amount and gently apply on to the face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADENOSINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62041-230-022024-01-30C16284748780-11030e365-586a-111a-e063-dadaa90a10e2aafaac5b-a4e9-4f09-a0ac-61990cb92264

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62041-230-01AAPE Continuous Renewal Eye20 mL in 1 CONTAINERCREAM201
62041-230-02AAPE Continuous Renewal Eye1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62041-230AAPE CONTINUOUS RENEWAL EYE (NIACINAMIDE, ADENOSINE) CREAM [PROSTEMICS CO., LTD.]1Legacy NDC, 2 package rows20190826_aafaac5b-a4e9-4f09-a0ac-61990cb92264.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
62041-23062041-230-01, 62041-230-02

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
Niacinamide25X51I8RD4ACTIB
AdenosineK72T3FS567ACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

Source Document#

Source XML · Source PDF

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
5dd23a58-4fed-4e52-93c8-144d1bc6aaadaafaac5b-a4e9-4f09-a0ac-61990cb922642019-08-26WarningsExact identifier
spl id: 5dd23a58-4fed-4e52-93c8-144d1bc6aaad
spl set id: aafaac5b-a4e9-4f09-a0ac-61990cb92264

Reported adverse events (FAERS/openFDA)#

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