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NDC 72630-0030-02 DR.PLINUS ZERO TROUBLE .0007; .029; .00001 mg/1.4mg; mg/1.4mg; mg/1.4mg Details

DR.PLINUS ZERO TROUBLE .0007; .029; .00001 mg/1.4mg; mg/1.4mg; mg/1.4mg

DR.PLINUS ZERO TROUBLE is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by S Skin Co., Ltd.. The primary component is EPIGALLOCATECHIN GALLATYL GLUCOSIDE; GLUCONOLACTONE; MADECASSOSIDE.

Product Information

NDC	72630-0030
Product ID	72630-030_e25994c4-c617-4eb9-999a-822d846670bb
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	DR.PLINUS ZERO TROUBLE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Gluconolactone, Epigallocatechin Gallatyl Glucoside, Madecassoside
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	.0007; .029; .00001
Active Ingredient Units	mg/1.4mg; mg/1.4mg; mg/1.4mg
Substance Name	EPIGALLOCATECHIN GALLATYL GLUCOSIDE; GLUCONOLACTONE; MADECASSOSIDE
Labeler Name	S Skin Co., Ltd.
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Irrigation [MoA]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72630-0030-02 (72630003002)

Pricing Information	N/A
NDC Package Code	72630-030-02
Billing NDC	72630003002
Package	9 PATCH in 1 CONTAINER (72630-030-02) / 1.4 mg in 1 PATCH (72630-030-01)
Marketing Start Date	2021-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ca117510-27f2-4344-8241-fdb564de1901 Details

ACTIVE INGREDIENTS

Gluconolactone 2.14%

Epigallocatechin Gallatyl Glucoside 0.05%

Madecassoside 0.0013%(13ppm)

INACTIVE INGREDIENTS

Sodium Hyaluronate, Water, Butylene Glycol, Niacinamide, Ectoin, 1.2-Hexanediol, Centella Asiatica Extract

PURPOSE

Exfoliation

Sebum control

Calming

WARNINGS

1. Discontinue to use or consult with dermatologist if irritation, swelling or itching appears after applying the product

2. Avoid applying patches on the wounded, dermatitis, and inflamed skin parts

3. Safety and storage precautions

A) Keep out of children's reach

B) Keep away from direct sunlight

C) Use immediately after opening

D) Do not reuse the patch you have already attached once

E) For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of children's reach

Uses

■ Helps with exfoliation

■ Helps sebum control

■ Helps to soothe your skin

Directions

① Before using the patch, wash your face.

② Open the pouch and take the patches out from the clear case, and remove the protective films on patch

(* one by one. At this point, be careful not to touch the middle part of the patch.)

③ Adjust the patches on your face where you concern and press lightly at a right angle.

④ Attach the patch above at least 60 minutes.

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

QUESTIONS

■ https://www.drplinus.com/ +82.1811.8665

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.PLINUS ZERO TROUBLE

gluconolactone, epigallocatechin gallatyl glucoside, madecassoside patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72630-030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLUCONOLACTONE (UNII: WQ29KQ9POT) (GLUCONOLACTONE - UNII:WQ29KQ9POT)	GLUCONOLACTONE	0.029 mg in 1.4 mg
EPIGALLOCATECHIN GALLATYL GLUCOSIDE (UNII: AR8RR3M6N9) (EPIGALLOCATECHIN GALLATYL GLUCOSIDE - UNII:AR8RR3M6N9)	EPIGALLOCATECHIN GALLATYL GLUCOSIDE	0.0007 mg in 1.4 mg
Madecassoside (UNII: CQ2F5O6YIY) (Madecassoside - UNII:CQ2F5O6YIY)	Madecassoside	0.00001 mg in 1.4 mg

Ingredient Name	Strength
Inactive Ingredients
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72630-030-02	9 in 1 CONTAINER	05/01/2021
1	NDC:72630-030-01	1.4 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/01/2021

Labeler - S Skin Co., Ltd. (694879753)

Registrant - S Skin Co., Ltd. (694879753)

Name	Address	ID/FEI	Business Operations
Establishment
BIOCOSONE CO.,LTD		695729438	manufacture(72630-030)

Revised: 10/2022

Document Id: e25994c4-c617-4eb9-999a-822d846670bb

Set id: ca117510-27f2-4344-8241-fdb564de1901

Version: 2

Effective Time: 20221018