WRINKLE SOLUTION CONCENTRATING ESSENCE SPECIAL SET- dimethicone

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

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)
Available from:
DN Company Co., Ltd.
Prescription type:
OTC DRUG
Therapeutic indications:
PURPOSE: Skin protectant, Anti Wrinkle Apply proper amount to the skin
Authorization status:
OTC monograph not final
Authorization number:
60565-016-01

WRINKLE SOLUTION CONCENTRATING ESSENCE SPECIAL SET- dimethicone

DN Company 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.

----------

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Dimethicone 0.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Glycerin, Butylene Glycol, Dipropylene Glycol,

Triethylhexanoin, Glycereth-26, Betaine, Polysorbate 60, Panthenol, Glycosyl Trehalose, etc.

PURPOSE

PURPOSE: Skin protectant, Anti Wrinkle

WARNINGS

WARNING: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or

rash appear. Keep out of reach of babies and children.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children.

INDICATIONS AND USAGE

Apply proper amount to the skin

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION: Recommended interval for mask application is every 2~3 days

for maximum efficiency. Wipe your body and neck with extra serum.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WRINKLE SOLUTION CONCENTRATING ESSENCE SPECIAL SET

dimethicone kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 56 5-0 16

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 56 5-0 16 -0 1

1 in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

0 4/28 /20 16

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

35 mL

Pa rt 2

1 BOTTLE

30 mL

Pa rt 3

1 BOTTLE

30 mL

Part 1 of 3

WRINKLE SOLUTION CONCENTRATING ESSENCE

dimethicone liquid

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

0 .5 g in 10 0 mL

GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)

GLYCERIN

8 .15338 5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

35 mL in 1 BOTTLE; 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 no t final

pa rt347

0 7/13/20 16

Part 2 of 3

WRINKLE SOLUTION SKIN SOFTNER

dimethicone liquid

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

0 .5 g in 10 0 mL

GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)

GLYCERIN

8 .15338 5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

30 mL in 1 BOTTLE; 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 no t final

pa rt347

0 7/13/20 16

Part 3 of 3

WRINKLE SOLUTION EMULSION

dimethicone cream

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

0 .5 g in 10 0 mL

GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)

GLYCERIN

8 .15338 5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

30 mL in 1 BOTTLE; 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

DN Company Co., Ltd.

OTC mo no graph no t final

pa rt347

0 7/13/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt347

0 4/28 /20 16

Labeler -

DN Company Co., Ltd. (688369859)

Registrant -

DN Company Co., Ltd. (688369859)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smax, Inc.

6 8 9 0 49 6 9 3

ma nufa c ture (6 0 56 5-0 16 )

Revised: 4/2019

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