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NDC 62041-0280-02 CellExosome SB 0.09 g/3mL Details

CellExosome SB 0.09 g/3mL

CellExosome SB 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	62041-0280
Product ID	62041-280_877364f8-39ff-4f37-a771-d77a9337a984
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	CellExosome SB
Proprietary Name Suffix	n/a
Non-Proprietary Name	Niacinamide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.09
Active Ingredient Units	g/3mL
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 62041-0280-02 (62041028002)

Pricing Information	N/A
NDC Package Code	62041-280-02
Billing NDC	62041028002
Package	5 CONTAINER in 1 CARTON (62041-280-02) / 3 mL in 1 CONTAINER (62041-280-01)
Marketing Start Date	2020-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 47708ea4-e54d-460a-9281-35195adce67c Details

ACTIVE INGREDIENT

Active ingredients: Niacinamide 3.0%

INACTIVE INGREDIENT

Inactive ingredients:

[Powder] HUMAN ADIPOSE DERIVED STEM CELL CONDITIONED MEDIA, Panax Ginseng Root Extract

[Solvent] Water, Tranexamic Acid, Water, 1,2-Hexanediol, Hydroxyacetophenone, Ascorbyl Glucoside, Sodium Hyaluronate

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 SECTION

Uses

Uses:

Helps brighten skin tone.

Directions

Directions:

■ Put solvent into the powder ampoule and shake gently enough to dissolve the mixture

■ Take proper amount and gently apply onto the skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CELLEXOSOME SB

niacinamide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62041-280
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	0.09 g in 3 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Tranexamic Acid (UNII: 6T84R30KC1)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62041-280-02	5 in 1 CARTON	02/01/2020
1	NDC:62041-280-01	3 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		02/01/2020

Labeler - PROSTEMICS Co., Ltd. (689605919)

Registrant - PROSTEMICS Co., Ltd. (689605919)

Name	Address	ID/FEI	Business Operations
Establishment
Prostemics Co., Ltd. Factory		695687674	manufacture(62041-280)

Revised: 2/2020

Document Id: 877364f8-39ff-4f37-a771-d77a9337a984

Set id: 47708ea4-e54d-460a-9281-35195adce67c

Version: 1

Effective Time: 20200214