Label: SBS 40 MEDICATED CREAM- allantoin cream

  • NDC Code(s): 11084-241-08, 11084-241-10, 11084-241-35, 11084-241-39
  • Packager: SC Johnson Professional USA, Inc.
  • 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 December 2, 2020

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

  • 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

    AQUA (WATER), CETYL ESTERS, PETROLATUM, ISOPROPYL PALMITATE, STEARYL ALCOHOL, CARBOMER, CETEARETH-20, CHLOROXYLENOL, METHYLPARABEN, LANOLIN, SODIUM HYDROXIDE, PROPYLPARABEN, PARFUM (FRAGRANCE).

  • PRINCIPAL DISPLAY PANEL

    SBS100ML-SBS-40 Medicated Skin Cream-V5b.jpg

    SBS100ML-SBS-40 Medicated Skin Cream-V5b.jpg

    deb stoko

    SBS-40

    Medicated Skin Cream

    Normal Skin

    Crema medicada para la piel

    Piel normal

    EN Skin conditioning cream. Ideal for irritated skin.

    Non-greasy. Non-irritating.

    ES Acondicionador para la piel. Ideal para la piel

    irritada. No es grasiento. No es irritante.

    100 ml (3.38 fl oz)

    Stock #:

    SBS100ML

    DCN8807/0115

    Deb USA, Inc.

    Charlotte, NC 28217

    1-800-248-7190

    www.debgroup.com Made in USA

  • INGREDIENTS AND APPEARANCE
    SBS 40 MEDICATED CREAM 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-241
    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)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-241-082500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/201306/30/2021
    2NDC:11084-241-35148 mL in 1 TUBE; Type 0: Not a Combination Product12/01/201304/01/2018
    3NDC:11084-241-3930 mL in 1 TUBE; Type 0: Not a Combination Product12/01/201301/28/2023
    4NDC:11084-241-10100 mL in 1 TUBE; Type 0: Not a Combination Product06/01/201502/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/01/201312/31/2023
    Labeler - SC Johnson Professional USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    SC Johnson Professional USA, Inc.078805627manufacture(11084-241)