AAPE SKIN AMPOULE- niacinamide liquid 
PROSTEMICS Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active ingredients: Niacinamide 2.00% 

INACTIVE INGREDIENT

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

Purpose: Skin Brightening

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Helps brighten skin tone.

Directions

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 carton

AAPE SKIN AMPOULE 
niacinamide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.12 g  in 6 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62041-250-016 mL in 1 CONTAINER; Type 0: Not a Combination Product08/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2019
Labeler - PROSTEMICS Co., Ltd. (689605919)
Registrant - PROSTEMICS Co., Ltd. (689605919)
Establishment
NameAddressID/FEIBusiness Operations
Prostemics Co., Ltd. Factory695687674manufacture(62041-250)

Revised: 8/2019
Document Id: b5a74e09-959a-4bc2-a0f4-e0c9194a3231
Set id: a0cfe424-aeb1-48ba-9572-4e9885c842da
Version: 1
Effective Time: 20190826
 
PROSTEMICS Co., Ltd.