Label: FERMENTED POMEGRANTE WHITENING SLEEPING MASK- dimethicone patch

  • Category: HUMAN OTC DRUG LABEL

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 September 22, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE 4%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, GLYCERETH-26, ARBUTIN, OLETH-15, HYDROGENATED LECITHIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, CARBOMER, LACTOBACILLUS/PUNICA GRANATUM FRUIT FERMENT EXTRACT, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, SORBITOL, TREHALOSE, TRIETHANOLAMINE, TOCOPHERYL ACETATE, SODIUM HYALURONATE, DISODIUM EDTA, DIACETYL BOLDINE, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE, CARAMEL

  • PURPOSE

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

  • WARNINGS

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FERMENTED POMEGRANTE WHITENING SLEEPING MASK 
    dimethicone patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-022
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    ARBUTIN (UNII: C5INA23HXF)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBITOL (UNII: 506T60A25R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARAMEL (UNII: T9D99G2B1R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-022-01100 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2011
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINFOOD CO., LTD.690324173manufacture
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