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

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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)