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NDC 62041-0240-01 AAPE Continuous Renewal Mask 0.6 g/30mL Details

AAPE Continuous Renewal Mask 0.6 g/30mL

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

Product Information

NDC	62041-0240
Product ID	62041-240_97a4a20a-87bc-473f-9436-5da9feb44f3d
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 Mask
Proprietary Name Suffix	n/a
Non-Proprietary Name	Niacinamide
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	0.6
Active Ingredient Units	g/30mL
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 62041-0240-01 (62041024001)

Pricing Information	N/A
NDC Package Code	62041-240-01
Billing NDC	62041024001
Package	30 mL in 1 POUCH (62041-240-01)
Marketing Start Date	2019-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL db3493c2-4c90-4a73-945d-743ed9cd8677 Details

ACTIVE INGREDIENT

Active ingredients: Niacinamide 2.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Butylene Glycol, Human Adipocyte Conditioned Media Extract, 1,2-Hexanediol, Sorbitol, Alcohol, Xanthan Gum, Caprylyl Glycol, Glycosyl Trehalose, PEG-60 Hydrogenated Castor Oil, Hydrogenated Starch Hydrolysate, Ascorbyl Glucoside, Allantoin, Hydroxyethylcellulose, Tromethamine, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Carbomer, Adenosine, Disodium EDTA, Dipotassium Glycyrrhizate, Panthenol, Glyceryl Citrate/Lactate/Linoleate/Oleate, Sodium Hyaluronate, Olea Europaea (Olive) Fruit Oil, Polysorbate 60, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Extract, Hydrolyzed Collagen, Palmitoyl Tripeptide-5, Acetyl Hexapeptide-8, Fragrance

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 out of reach of children.

5. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Helps brighten skin tone.

Directions

Directions:

1. After washing your face, arrange your skin texture with toner.

2. Take out the mask sheet and put it on your entire face except around the eyes and lips.

3. Take off the sheet 10~15 min. later and tap it gently to let the remaining essence be absorbed into the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AAPE CONTINUOUS RENEWAL MASK

niacinamide patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62041-240
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	0.60 g in 30 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62041-240-01	30 mL in 1 POUCH; 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(62041-240)

Revised: 8/2019

Document Id: 97a4a20a-87bc-473f-9436-5da9feb44f3d

Set id: db3493c2-4c90-4a73-945d-743ed9cd8677

Version: 1

Effective Time: 20190826