Label: CLAPIEL REVITAL SERUM- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69977-040-01 - Packager: AUS KOREA CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 24, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLAPIEL REVITAL SERUM
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69977-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 6.0 mg in 30 mL Inactive Ingredients Ingredient Name Strength Squalane (UNII: GW89575KF9) JOJOBA OIL (UNII: 724GKU717M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69977-040-01 30 mL in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/01/2015 Labeler - AUS KOREA CO., LTD. (689515251) Registrant - AUS KOREA CO., LTD. (689515251) Establishment Name Address ID/FEI Business Operations AUS KOREA CO., LTD. 689515251 manufacture(69977-040)