Label: SBS 40- allantoin lotion

  • 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 3, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient

    Allantoin, 0.5%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    Temporarily protects and helps relieve chapped or cracked skin

    Helps protect from the drying effects of wind and cold weather

  • WARNINGS

    Warnings

    For external use only


    When using this product do not get in eyes

    Stop use and ask a doctor if

    conditions worsen

    symptoms last more than 7 days

    or clear up and occur again within a few days

    Enter section text here

    Keep out of the reach of children

  • DOSAGE & ADMINISTRATION

    Directions

    Apply SBS-40 as needed

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Stearyl Alcohol, Carbomer, Triethanolamine, Ceteareth-20, Chloroxylenol, Methylparaben, Lanolin, Propylparaben, Fragrance, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL

    deb

    SBS 40

    Medicated Skin Cream

    Skin Protectant

    1-Protect

    2-Cleanse

    3-Restore

    85 fl. oz. 2.5 liters

    Made in U.S.A.

    40108-05-026

    Contains a blend of emollients including lanolin to keep skin soft and supple.

    Recommended for professionals and individuals who have chapped or cracker hands.

    Soothes and protects dry or chapped skin

    container label

  • INGREDIENTS AND APPEARANCE
    SBS 40 
    allantoin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin0.5 mL  in 100  mL
    Inactive Ingredients
    Ingredient NameStrength
    Cetyl Esters Wax (UNII: D072FFP9GU)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Carbomer 934 (UNII: Z135WT9208)  
    Trolamine (UNII: 9O3K93S3TK)  
    Chloroxylenol (UNII: 0F32U78V2Q)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Lanolin (UNII: 7EV65EAW6H)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-040-082500 mL in 1 BOTTLE, PLASTIC
    2NDC:11084-040-35148 mL in 1 TUBE
    3NDC:11084-040-3930 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2010
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.607378015manufacture
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