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NDC 62041-0230-02 AAPE Continuous Renewal Eye .008; .4 g/20mL; g/20mL Details

AAPE Continuous Renewal Eye .008; .4 g/20mL; g/20mL

AAPE Continuous Renewal Eye is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by PROSTEMICS Co., Ltd.. The primary component is ADENOSINE; NIACINAMIDE.

Product Information

NDC	62041-0230
Product ID	62041-230_5dd23a58-4fed-4e52-93c8-144d1bc6aaad
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 Continuous Renewal Eye
Proprietary Name Suffix	n/a
Non-Proprietary Name	Niacinamide, Adenosine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.008; .4
Active Ingredient Units	g/20mL; g/20mL
Substance Name	ADENOSINE; NIACINAMIDE
Labeler Name	PROSTEMICS Co., Ltd.
Pharmaceutical Class	Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 62041-0230-02 (62041023002)

Pricing Information	N/A
NDC Package Code	62041-230-02
Billing NDC	62041023002
Package	1 CONTAINER in 1 CARTON (62041-230-02) / 20 mL in 1 CONTAINER (62041-230-01)
Marketing Start Date	2019-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aafaac5b-a4e9-4f09-a0ac-61990cb92264 Details

ACTIVE INGREDIENT

Active ingredients: Niacinamide 2.00%, Adenosine 0.04%

INACTIVE INGREDIENT

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

Purpose: Skin Brightening, Anti wrinkle

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. Replace the cap after use

5. Keep out of reach of children.

6. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Helps brighten skin tone.

Helps improve wrinkle problem.

Directions

Directions:

Take proper amount and gently apply on to the face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AAPE CONTINUOUS RENEWAL EYE

niacinamide, adenosine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62041-230
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	0.40 g in 20 mL
Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	Adenosine	0.008 g in 20 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62041-230-02	1 in 1 CARTON	08/01/2019
1	NDC:62041-230-01	20 mL in 1 CONTAINER; Type 0: Not a Combination Product

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(62041-230)

Revised: 8/2019

Document Id: 5dd23a58-4fed-4e52-93c8-144d1bc6aaad

Set id: aafaac5b-a4e9-4f09-a0ac-61990cb92264

Version: 1

Effective Time: 20190826