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NDC 62041-0220-02 AAPE Continuous Renewal .02; 1 g/50mL; g/50mL Details

AAPE Continuous Renewal .02; 1 g/50mL; g/50mL

AAPE Continuous Renewal 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	62041-0220
Product ID	62041-220_5c34aae5-aab6-4b26-af35-694880234c4b
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Niacinamide, Adenosine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.02; 1
Active Ingredient Units	g/50mL; g/50mL
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 62041-0220-02 (62041022002)

Pricing Information	N/A
NDC Package Code	62041-220-02
Billing NDC	62041022002
Package	1 CONTAINER in 1 CARTON (62041-220-02) / 50 mL in 1 CONTAINER (62041-220-01)
Marketing Start Date	2019-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f8e09b8e-093d-47d5-a297-7364c89bb3f4 Details

ACTIVE INGREDIENT

Active ingredients: Niacinamide 2.00%, Adenosine 0.04%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Human Adipocyte Conditioned Media Extract

Glycerin, Butylene Glycol, Cyclopentasiloxane, Olea Europaea (Olive), Fruit Oil, Cetyl Ethylhexanoate, Octyldodecyl, Myristate, PEG-40 Stearate, Helianthus Annuus (sunflower) Seed Oil, Cyclohexasiloxane, Glyceryl Stearate, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, PEG-100 Stearate, Dimethicone, Diisostearyl Malate, Caprylyl Glycol, Sorbitan Sesq ioleate, Ethylhexylglycerin, BeesWax, Butyrospermum Parkii (Shea) Butter, Carbomer, Tromethamine, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyacrylate-13, Glyceryl Citrate/Lactate/Linoleate/Oleate, 1,2-Hexanediol, Polyisobutene, Polysorbate 60, Sodium Hyaluronate, Polysorbate 20, Sorbitan Isostearate, Beta-Glucan, Hydrolyzed, Extensin, Tocopherol, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Convallaria Majalis, Bulb/Root Extract, Magnolia Liliflora Flower Extract, Paeonia Lactiflora Extract, Acetyl Hexapeptide-8, 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

niacinamide, adenosine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62041-220
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	1.00 g in 50 mL
Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	Adenosine	0.02 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62041-220-02	1 in 1 CARTON	08/01/2019
1	NDC:62041-220-01	50 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(62041-220)

Revised: 8/2019

Document Id: 5c34aae5-aab6-4b26-af35-694880234c4b

Set id: f8e09b8e-093d-47d5-a297-7364c89bb3f4

Version: 1

Effective Time: 20190826