Label: EIGHT HOUR NIGHT- dimethicone emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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  • Active Ingredient

    Active Ingredient Purpose
    Dimethicone 2.0%...................................... Skin Protectant

  • Inactive Ingredients

    PETROLATUM, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, LANOLIN, ISONONYL ISONONANOATE, HYDROGENATED POLYISOBUTENE, ISOPROPYL MYRISTATE, ISOPROPYL PALMITATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, POLYBUTENE, TRIISOSTEARIN, OLEYL ERUCATE, POLYPROPYLENE, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, SYNTHETIC WAX, CYCLOPENTASILOXANE, RICINUS COMMUNIS (CASTOR) SEED OIL, GLYCERYL BEHENATE/EICOSADIOATE, HYDROGENATED LECITHIN, DIMETHICONOL, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, PARFUM/FRAGRANCE, SALICYLIC ACID, TOCOPHEROL, TOCOPHERYL ACETATE, VEGETABLE OIL/OLUS/HUILE VEGETALE, ALPHA-ISOMETHYL IONONE, BENZYL SALICYLATE, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, YELLOW 6 LAKE (CI 15985).

  • Uses and Directions

    Uses
    - Treats symptoms of chapped or cracked skin.
    - Helps prevent and protect from drying effects of wind and cold weather.

    Directions

    - Apply liberally as often as necessary

  • Warnings

    Warnings
    For external use only
    When using this product
    - Avoid contact with eyes

    - Do not apply over puncture wounds, infections or lacerations

    Stop using and ask a doctor if
    - Symptoms persist more than 7 days

  • DOSAGE & ADMINISTRATION

    As Needed

  • INDICATIONS & USAGE

    • Treats symptoms of chapped or cracked skin
    • Helps prevent and protect from drying effects of wind and cold weather
  • PURPOSE

    Skin Protectant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • carton art

    eight hr night

  • INGREDIENTS AND APPEARANCE
    EIGHT HOUR NIGHT 
    dimethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-675
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    OLEYL ERUCATE (UNII: 753W099NQ6)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CORN OIL (UNII: 8470G57WFM)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LANOLIN (UNII: 7EV65EAW6H)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    GERANIOL (UNII: L837108USY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYPROPYLENE (30000 MW) (UNII: T71QXI2O62)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-675-1645 g in 1 JAR; Type 0: Not a Combination Product10/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/20/2020
    Labeler - REVLON (788820165)
    Registrant - REVLON (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Revlon809725570manufacture(10967-675)