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Power Ampoule Whitening

Medically reviewed on January 1, 2018

Dosage form: solution
Ingredients: Dimethicone 0.72g in 40mL
Labeler: The Saem International Co., Ltd.
NDC Code: 70341-460

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 Ingredients: Dimethicone 1.8%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Butylene Glycol, Niacinamide, Methyl Gluceth-10, Triethylhexanoin, Pentaerythrityl Tetraethylhexanoate, Glyceryl Stearate, PEG-100 Stearate, Portulaca Oleracea Extract, Cetearyl Olivate, Sorbitan Olivate, Cyclopentasiloxane, Cyclohexasiloxane, Dimethiconol, Phenoxyethanol, Chlorphenesin, Glycine Soja (Soybean) Sterols, Mica (CI 77019), Titanium Dioxide (CI 77891), Actinidia Polygama Fruit Extract, PEG-5 Rapeseed Sterol, Ceteth-4, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cholesterol, Bacillus/Soybean Ferment Extract, Disodium EDTA, Potassium Hydroxide, Tocopheryl Acetate, Perfume, Potassium Cetyl Phosphate, Pyridoxine HCl, Magnesium Ascorbyl Phophate, Panthenol, Linoleic Acid, Linolenic Acid, Retinyl Palmitate, Caprylyl Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Biotin

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

POWER AMPOULE WHITENING 
dimethicone solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-460
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (DIMETHICONE) Dimethicone0.72 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:70341-460-0140 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2015
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIOperations
The Saem International Co., Ltd.689402402manufacture(70341-460)

 
The Saem International Co., Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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