Label: SBS 40- allantoin cream

  • 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 February 15, 2017

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  • Active ingredient

    Allantoin, 0.5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve chapped or cracked skin

    Helps protect from the drying effects of wind and cold weather

  • Warnings

    For external use only

    Do not use on

    deep or puncture wounds

    animal bites

    serious burns

    When using this product

    avoid contact with eyes.

    In case of eye contact, flush with water.

    Stop use and ask a doctor if

    irritation or sensitivity develops

    condition worsens

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

    Keep out of reach of children

  • Directions

    apply to clean, dry hands as needed

    rub in well

  • Inactive ingredients

    Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Phenoxyethanol, Stearyl Alcohol, Carbomer, Triethanolamine, Diazolidinyl Urea, Ceteareth-20, Lanolin, Fragrance

  • PRINCIPAL DISPLAY PANEL

    product label

    deb

    SBS 40

    Medicated Skin Cream

    Silicone-free

    Non-irritating

    Non-greasy formulation

    Helps heal dry hard-working hands

    Industry's preferred brand for over 50 years

    2.5 Liter

    85 Fluid Ounces

    USDA Certified Biobased Product

    Made in USA

    Deb USA, Inc.

    Charlotte, NC 28217

    1-800-248-7190

    www.debgroup.com

    40108

    Rev. 01-13

  • INGREDIENTS AND APPEARANCE
    SBS 40 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-240-082500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201303/01/2017
    2NDC:11084-240-35148 mL in 1 TUBE; Type 0: Not a Combination Product01/01/201303/01/2017
    3NDC:11084-240-3930 mL in 1 TUBE; Type 0: Not a Combination Product01/01/201303/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2013
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.078805627manufacture(11084-240)
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