Power Ampoule Anti wrinkle by The Saem International Co., Ltd.

Drug Details [pdf]

POWER AMPOULE ANTI WRINKLE- glycerin solution
The Saem International Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredients: GLYCERIN 5.93%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, ALCOHOL, CYCLOPENTASILOXANE, AUREOBASIDIUM PULLULANS FERMENT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PIPER METHYSTICUM LEAF/ROOT/STEM EXTRACT, HYDROGENATED LECITHIN, DIMETHICONE, 1,2-HEXANEDIOL, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, BETA-GLUCAN, BIFIDA FERMENT LYSATE, PHENOXYETHANOL, ARCTIUM LAPPA ROOT EXTRACT, PHELLINUS LINTEUS EXTRACT, DIMETHICONE CROSSPOLYMER, XANTHAN GUM, CERAMIDE 3, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ETHYLHEXYLGLYCERIN, SODIUM CITRATE, PORTULACA OLERACEA EXTRACT, PUERARIA THUNBERGIANA ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, DIOSCOREA JAPONICA ROOT EXTRACT, TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT, C12-14 PARETH-7, SOLUBLE COLLAGEN, LAURETH-4, SUCROSE PALMITATE, LAURETH-23, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, SODIUM HYALURONATE, ADENOSINE, CITRIC ACID, ALOE BARBADENSIS LEAF JUICE, DIPROPYLENE GLYCOL, PEG-10 RAPESEED STEROL, DISODIUM EDTA, FRAGRANCE, ARGANIA SPINOSA KERNEL OIL, PEG-60 HYDROGENATED CASTOR OIL, GLYCERYL STEARATE, BUTYLENE GLYCOL, GLYCERETH-20, CARAMEL, PROPYLENE GLYCOL, FOLIC ACID, CHOLESTEROL, RAFFINOSE, ACACIA SENEGAL GUM, POTASSIUM SORBATE, TROMETHAMINE, ACETIC ACID, LACTIC ACID, PANTHENOL, PALMITOYL PENTAPEPTIDE-4, BHT

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indication & Usage: Use after washing the face and before applying serum. Apply an appropriate amount and pat face lightly to enhance absorption into skin.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

POWER AMPOULE ANTI WRINKLE
glycerin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-090
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2.37 g in 40 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-090-01	40 mL in 1 CARTON; Type 0: Not a Combination Product	12/01/2015	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/01/2015	11/01/2019

Labeler - The Saem International Co., Ltd. (689402402)

Registrant - The Saem International Co., Ltd. (689402402)

Name	Address	ID/FEI	Business Operations
Establishment
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(70341-090)

Revised: 12/2019

Document Id: a67d219f-0279-40cc-b18b-38c191c2bd30

Set id: 9e7079f1-20b4-4093-bca4-328d54621f43

Version: 2

Effective Time: 20191230