Label: SKINCEUTICALS ADVANCED SCAR CONTROL SKIN PROTECTANT- allantoin gel

  • NDC Code(s): 49967-783-01, 49967-783-02, 49967-783-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Active ingredient

    Allantoin 0.5%

  • Purpose

    Skin protectant

  • Uses

    temporarily protects minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • When using this product

    do not get into eyes

  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ● apply as needed

  • Inactive ingredients

    dimethicone, dimethicone crosspolymer, helianthus annuus (sunflower) seed oil unsaponifiables, silica silylate, acrylates/dimethicone copolymer, jojoba esters, helianthus annuus (sunflower) seed wax, acacia decurrens flower wax, polyglycerin-3

  • Questions or comments?

    Call 1-800-811-1660

    Monday - Friday (9 a.m. - 5 p.m. CST)

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    SKINCEUTICALS ADVANCED SCAR CONTROL SKIN PROTECTANT 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-783
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-783-011 in 1 CARTON06/01/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-783-024 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2021
    3NDC:49967-783-031 in 1 CARTON06/01/2021
    350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/01/2021
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Manufacturing Solutions Corp.783200723manufacture(49967-783)
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