SIERO TURNOVER 21 CREA M PACK- dimethicone cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
JNG KOREA CO.,LTD.
INN (International Name):
Dimethicone
Composition:
Dimethicone 2.0 g in 50 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Skin Protectant Uses: A home peeling cream pack that makes your skin that is dry and flaky from dead skin smooth and moisturized while sleeping pH 4.2 mildly acidic sleeping cream pack contains gluconolactone, a type of PHA, and lactobionic acid to take care of the dead skin cells gently at night by shortening their turnover cycle to 21 days for a healthy and smooth skin texture.
Authorization status:
OTC monograph final
Authorization number:
71472-010-01, 71472-010-02

SIERO TURNOVER 21 CREA M PACK- dimethicone cream

JNG KOREA CO.,LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active ingredients: Dimethicone 4.0%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Dipropylene Glycol, Butylene Glycol, Stearic Acid, Isopropyl

Myristate, Cetyl Alcohol, Gluconolactone, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Stearate SE,

Portulaca Oleracea Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phenoxyethanol,

Carbomer, Chlorphenesin, Potassium Hydroxide, Lactobionic Acid, Citrus Aurantium Dulcis (Orange)

Oil, t-Butyl Alcohol, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Disodium

EDTA, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Pelargonium

Graveolens Flower Oil, Ocimum Basilicum (Basil) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil,

Salvia Sclarea (Clary) Oil

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: - Keep away from direct sunlight and high temperature. - Use only at night. - For external use

only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap

after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Us es

Uses: A home peeling cream pack that makes your skin that is dry and flaky from dead skin smooth and

moisturized while sleeping pH 4.2 mildly acidic sleeping cream pack contains gluconolactone, a type of

PHA, and lactobionic acid to take care of the dead skin cells gently at night by shortening their turnover

cycle to 21 days for a healthy and smooth skin texture.

Directions

Directions: Before going to bed, apply to the entire face as the last step of skin care and let it absorb.

(Do not use during the day.)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIERO TURNOVER 21 CREA M PACK

dimethicone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71472-0 10

Route of Administration

TOPICAL

JNG KOREA CO.,LTD.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

Dime thic o ne

2.0 g in 50 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71472-0 10 -0 2

1 in 1 CARTON

0 6 /0 1/20 17

1

NDC:71472-0 10 -0 1

50 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 6 /0 1/20 17

Labeler -

JNG KOREA CO.,LT D. (557796103)

Registrant -

JNG KOREA CO.,LT D. (557796103)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

JNG KOREA CO.,LTD.

55779 6 10 3

re la be l(71472-0 10 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hanko o k Co smetics Manufacturing Co .,Ltd_Eumseo ng Facto ry

6 8 8 2356 45

ma nufa c ture (71472-0 10 )

Revised: 6/2017

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