Label: NIGHTLY FACE TREATMENT - DIMETHICONE- dimethicone cream

  • NDC Code(s): 71593-101-11, 71593-101-51
  • Packager: ARG LABS
  • 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 May 15, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    DIMETHICONE 1.5%

  • PURPOSE

    SKIN PROTECTANT

  • USES

    • Temporarily protects and helps relieve chapped or cracked skin.
    • Helps protect from the drying effect of wind and cold weather.

  • WARNINGS

    For external use only


    When using this product
    • Do not get into eyes

    Stop use and ask a doctor if
    • Condition worsens

    • Symptoms last more than 7 days or clear up and occur again within a few days

    Do not use

    • On deep puncture wounds

    • Animal bites

    • Serious burns

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Apply as needed. After cleansing skin thoroughly, apply four (+/-) pumps to face and neck. Apply to slightly damp skin for optimal absorption. Rinse skin in the morning following usage.

  • INACTIVE INGREDIENTS

    WATER (AQUA), ALOE BARBADENSIS LEAF JUICE, HYDROLYZED EGG SHELL MEMBRANE, NERIUM OLEANDER LEAF EXTRACT, NIACINAMIDE GLYCERIN, PROPANEDIOL,BUTYLENE GLYCOL, GLYCERYL STEARATE, Hydroxyethylacrylate/Sodium
    Acryloyldimethyltaurate Copolymer, Hydrogenated Polydecene, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SQUALANE, Cetearyl Olivate, Sorbitan Olivate, C12-15 Alkyl Benzoate, Stearic Acid, LEUCONOSTOC/RADISH ROOT FERMENT, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Polysorbate 80, CAPRYLYL GLYCOL, SALVIA HISPANICA (CHIA) SEED OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, Sodium Lactate, Tocopheryl Acetate, Xanthan Gum, Cymbopogon Schoenanthus Extract, Disodium EDTA, Acetyl Hexapeptide-30, Alteromonas Ferment Extract, Arginine, Caramel, POTASSIUM SORBATE, GLYCERYL CAPRYLATE, PHENYLPROPANOL, Limonene, Citral, Hydroxycitronellal, Linalool.

  • QUESTIONS?

    1-(844)-599-7787  M-F (9 AM TO 5 PM CST)

  • PRINCIPAL DISPLAY PANEL

    NSC.ADV.NC.Carton.30ml.UNV.V7_Page_1NSC.NeriumRX.NC.Carton.30ml.USA.HK.TK.KW.V12.LR_Page_1

  • INGREDIENTS AND APPEARANCE
    NIGHTLY FACE TREATMENT - DIMETHICONE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71593-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EGG SHELL MEMBRANE (UNII: N7QBR4212V)  
    NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SQUALANE (UNII: GW89575KF9)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SALVIA HISPANICA SEED (UNII: NU0OLX06F8)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CYMBOPOGON SCHOENANTHUS WHOLE (UNII: RJJ0F54DE8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ACETYL HEXAPEPTIDE-49 (UNII: 4055X1S509)  
    ALTEROMONAS MACLEODII (UNII: BPX036043D)  
    ARGININE (UNII: 94ZLA3W45F)  
    CARAMEL (UNII: T9D99G2B1R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRAL (UNII: T7EU0O9VPP)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71593-101-511 in 1 BOX12/06/2017
    1NDC:71593-101-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/06/2017
    Labeler - ARG LABS (049099177)