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NDC 62041-0250-01 AAPE Skin Ampoule 0.12 g/6mL Details

AAPE Skin Ampoule 0.12 g/6mL

AAPE Skin Ampoule is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by PROSTEMICS Co., Ltd.. The primary component is NIACINAMIDE.

Product Information

NDC	62041-0250
Product ID	62041-250_b5a74e09-959a-4bc2-a0f4-e0c9194a3231
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	AAPE Skin Ampoule
Proprietary Name Suffix	n/a
Non-Proprietary Name	Niacinamide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.12
Active Ingredient Units	g/6mL
Substance Name	NIACINAMIDE
Labeler Name	PROSTEMICS Co., Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 62041-0250-01 (62041025001)

Pricing Information	N/A
NDC Package Code	62041-250-01
Billing NDC	62041025001
Package	6 mL in 1 CONTAINER (62041-250-01)
Marketing Start Date	2019-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a0cfe424-aeb1-48ba-9572-4e9885c842da Details

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

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

INGREDIENTS AND APPEARANCE

AAPE SKIN AMPOULE

niacinamide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62041-250
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	0.12 g in 6 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62041-250-01	6 mL in 1 CONTAINER; Type 0: Not a Combination Product	08/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/01/2019

Labeler - PROSTEMICS Co., Ltd. (689605919)

Registrant - PROSTEMICS Co., Ltd. (689605919)

Name	Address	ID/FEI	Business Operations
Establishment
Prostemics Co., Ltd. Factory		695687674	manufacture(62041-250)

Revised: 8/2019

Document Id: b5a74e09-959a-4bc2-a0f4-e0c9194a3231

Set id: a0cfe424-aeb1-48ba-9572-4e9885c842da

Version: 1

Effective Time: 20190826