Label: FERMENTED SOY MILK WRINKLE CARE SLEEPING MASK - dimethicone patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/11

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE 4%

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  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, GLYCERETH-26, OLETH-15, HYDROGENATED LECITHIN, CARBOMER, LACTOBACILLUS/SOYMILK FERMENT FILTRATE, GLYCERIN, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, SORBITOL, TREHALOSE, TRIETHANOLAMINE, TOCOPHERYL ACETATE, LECITHIN, ADENOSINE, SODIUM HYALURONATE, DISODIUM EDTA, POLYSORBATE 20, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE

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  • PURPOSE

    Purpose: This combination of cosmetics / OTC Drug is used for your basic skin care and gives a benefit for  wrinkle care.

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  • WARNINGS

    Warnings:
    For external use only.
    Avoid contact with eyes.
    Discontinue use if signs of irritation appear.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of children.

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  • INDICATIONS & USAGE

    Indication and usage:
    Evenly apply an adequate amount in a circular motion on face and leave if for absorption.
    Use at the cream stage of your night skin care routine.

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  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    After applying the toner and the moisturizer at night, apply an appropriate amount and massage it to spread a veil onto the skin for absorption.

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  • INGREDIENTS AND APPEARANCE
    FERMENTED SOY MILK WRINKLE CARE SLEEPING MASK 
    dimethicone patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-021
    Route of Administration CUTANEOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 4 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBITOL (UNII: 506T60A25R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ADENOSINE (UNII: K72T3FS567)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76214-021-01 100 g in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/01/2011
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    Name Address ID/FEI Business Operations
    SKINFOOD CO., LTD. 690324173 manufacture
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