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NDC 62041-0200-02 AAPE Nutrient Facial Toner 2.6 g/130mL Details

AAPE Nutrient Facial Toner 2.6 g/130mL

AAPE Nutrient Facial Toner 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	62041-0200
Product ID	62041-200_b3440599-8ce1-4645-b192-8f0609487eeb
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 Nutrient Facial Toner
Proprietary Name Suffix	n/a
Non-Proprietary Name	Niacinamide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	2.6
Active Ingredient Units	g/130mL
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 62041-0200-02 (62041020002)

Pricing Information	N/A
NDC Package Code	62041-200-02
Billing NDC	62041020002
Package	1 CONTAINER in 1 CARTON (62041-200-02) / 130 mL in 1 CONTAINER (62041-200-01)
Marketing Start Date	2019-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 37ef6a58-23b4-4ce5-b47d-eb176dc0c3d4 Details

ACTIVE INGREDIENT

Active ingredients: Niacinamide 2.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Butylene Glycol, PEG/PPG-17/6 Copolymer, Trehalose, Human Adipocyte Conditioned Media Extract, 1,2-Hexanediol, Caprylyl Glycol, Bis-PEG-18 Methyl Ether Dimethyl Silane, Ethylhexylglycerin, Salix Alba (Willow) Bark Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Glycerin, Cellulose Gum, Panthenol, PEG-60 Hydrogenated Castor Oil, Hamamelis Virginiana (Witch Hazel) Leaf Water, Disodium EDTA, Glyceryl Citrate/Lactate/Linoleate/Oleate, Sodium Hyaluronate, Olea Europaea (Olive) Fruit Oil, Polysorbate 60, Lilium Candidum, Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Convallaria Majalis Bulb/Root Extract, Magnolia Liliflora Flower Extract, Paeonia Lactiflora Extract, Palmitoyl Tripeptide-5, 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. 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.

Directions

Directions:

Take proper amount and gently apply onto the face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AAPE NUTRIENT FACIAL TONER

niacinamide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62041-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	2.60 g in 130 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62041-200-02	1 in 1 CARTON	08/01/2019
1	NDC:62041-200-01	130 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(62041-200)

Revised: 8/2019

Document Id: b3440599-8ce1-4645-b192-8f0609487eeb

Set id: 37ef6a58-23b4-4ce5-b47d-eb176dc0c3d4

Version: 1

Effective Time: 20190822