AAPE Skin Ampoule

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 Skin Ampoule
Active ingredientNiacinamide
Label structure8 sections

Indications and uses

Uses: Helps brighten skin tone.

Dosage and administration

Directions: Gently mix with AAPE powder to dissolve the mixture. Take proper amount and gently apply onto the skin.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Niacinamide 2.00% 

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Water, Butylene Glycol, Glycerin, Sorbitol, Hydroxyacetophenone, Propanediol, Xanthan Gum, Allantoin, Adenosine, Caprylhydroxamic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Sophora Angustifolia Root Extract, Angelica Gigas Root Extract, Panax Ginseng Root Extract, Cnidium Officinale Root Extract, Glycine Max (Soybean) Seed Extract, Polygonum Multiflorum Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Acetyl Hexapeptide-8, Palmitoyl Tripeptide-5

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Brightening

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. Keep in the refrigerator at 2-6°C.
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.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:
Gently mix with AAPE powder to dissolve the mixture.
Take proper amount and gently apply onto the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62041-250-012024-01-30C16284748780-11030e365-5dd5-111a-e063-dadaa90a10e2a0cfe424-aeb1-48ba-9572-4e9885c842da

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62041-250-01AAPE Skin Ampoule6 mL in 1 CONTAINERLIQUID61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62041-250AAPE SKIN AMPOULE (NIACINAMIDE) LIQUID [PROSTEMICS CO., LTD.]1Legacy NDC, 1 package rows20190826_a0cfe424-aeb1-48ba-9572-4e9885c842da.zip

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
62041-25062041-250-01

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
Niacinamide25X51I8RD4ACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

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
b5a74e09-959a-4bc2-a0f4-e0c9194a3231a0cfe424-aeb1-48ba-9572-4e9885c842da2019-08-26WarningsExact identifier
spl id: b5a74e09-959a-4bc2-a0f4-e0c9194a3231
spl set id: a0cfe424-aeb1-48ba-9572-4e9885c842da

Reported adverse events (FAERS/openFDA)#

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