AAPE SKIN AMPOULE- niacinamide liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)
Available from:
PROSTEMICS Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Skin Brightening Uses: Helps brighten skin tone.
Authorization status:
unapproved drug other
Authorization number:
62041-250-01

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

Us es

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

AAPE SKIN AMPOULE

niacinamide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 20 41-250

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Nia cina mide (UNII: 25X51I8 RD4) (NIACINAMIDE - UNII:25X51I8 RD4)

Nia c ina mide

0 .12 g in 6 mL

PROSTEMICS Co., Ltd.

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 20 41-250 -0 1 6 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 8 /0 1/20 19

Labeler -

PROST EMICS Co., Ltd. (689605919)

Registrant -

PROST EMICS Co., Ltd. (689605919)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pro stemics Co ., Ltd. Facto ry

6 9 56 8 76 74

ma nufa c ture (6 20 41-250 )

Revised: 8/2019

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