Label: ALL DAY SKIN RELIEF WITH COLLOIDAL OATS- cetyl alcohol lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 16, 2016

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  • ACTIVE INGREDIENT

    ETYL ALCOHOL 0.80%

  • PURPOSE

    Skin Protectant

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    INDICATION AND USAGE

    Relieves dry, itchy skin and provides hydration.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    Adults and children over two years of age. Apply up to 3-4 times a day.

    Chilldren under two years of age, consult a physician.

  • WARNINGS

    WARNING

    • For external use only - hands
    • Stop use and contact a doctor if condition worsens and does not improve in seven days.
    • Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water
  • INACTIVE INGREDIENTS

    WATER

    GLYCERIN

    DISTEARYLDIMONIUM CHLORIDE

    PETROLATUM

    ISOPROPYL PALMITATE

    AVENA SATIVA (OAT) KERNEL FLOUR

    BENZYL ALCOHOL

    AVENA SATIVA (OAT) KERNEL OIL

    STEARETH-20

    AVENA SATIVA (OAT) KERNEL EXTRACT

    BUTYROSPERMUM PARKII (SHEA BUTTER)

    SODIUM CHLORIDE

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALL DAY SKIN RELIEF WITH COLLOIDAL OATS 
    cetyl alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50306-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYL ALCOHOL (UNII: 936JST6JCN) (CETYL ALCOHOL - UNII:936JST6JCN) CETYL ALCOHOL80 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
    STEARETH-20 METHACRYLATE (UNII: A268NZ57NB)  
    SODIUM CHLORIDE NA-22 (UNII: VMP9781061)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL (UNII: S8TT5K3C8Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50306-011-50354 mL in 1 BOTTLE; Type 0: Not a Combination Product05/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/16/2016
    Labeler - Shanghai Lantern Cosmetic Co (421252043)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Lantern Cosmetic Co421252043manufacture(50306-011)
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