CLAPIEL REVITAL SERUM- dimethicone cream 
AUS 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 Ingredient: Dimethicone 20.0%

INACTIVE INGREDIENT

Inactive Ingredients: Cyclopentasiloxane, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Cyclohexasiloxane, Linum Usitatissimum (Linseed) Seed Oil, Camellia Japonica Seed Oil, Macadamia Ternifolia Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Pichia Anomala Extract, Yeast Extract, Myrothamnus Flabellifolia Callus Culture Extract, Pentylene Glycol, Hydrolyzed Myrtus Communis Leaf Extract, Undaria Pinnatifida Extract, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Chenopodium Album Flower Extract, Lactobacillus/Soybean Ferment Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Scultellaria Baicalensis Root Extract, Portulaca Oleracea Extract

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 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 babies and children

INDICATIONS & USAGE

Indications & Usage: Apply a desired amount evenly over entire face.

DOSAGE & ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CLAPIEL REVITAL SERUM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69977-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone6.0 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Squalane (UNII: GW89575KF9)  
JOJOBA OIL (UNII: 724GKU717M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69977-040-0130 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2015
Labeler - AUS KOREA CO., LTD. (689515251)
Registrant - AUS KOREA CO., LTD. (689515251)
Establishment
NameAddressID/FEIBusiness Operations
AUS KOREA CO., LTD.689515251manufacture(69977-040)

Revised: 7/2015
Document Id: adfd7f1c-08da-4038-a450-6639ff56a5bc
Set id: 91ed69fe-000f-4273-a323-0a856b6e5539
Version: 1
Effective Time: 20150724
 
AUS KOREA CO., LTD.