Label: SSEUG SSAGCREAM- xanthium strumarium fruit extract, canavalia gladiata extract cream

  • NDC Code(s): 74721-0100-1
  • Packager: S-ONE PHARMACEUTICAL INC
  • 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 January 2, 2023

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

  • Active ingredients

    - Xanthium Strumarium Fruit Extract 10%(w/w)
    - Canavalia Gladiata Extract 5%(w/w)

  • Purpose

    Hand & Feet skin softening product

  • Use

    It is a cream made by using xanthium strumarium fruit extract
    as the main ingredient and helps various skin problems.

  • Warnings

    For external use only.

    Make sure to close the cap after use.

  • Do not use

    Do not use it if you have red spots,
    swelling, itching or irritation on skin during use

    Do not use it if the area of application is abnormal
    due to direct sunlight.

    Do not use this product on skin with wounds or bleeding.

    Do not use eat this product, and if ingested,
    consult a specialist immediately.

    Do not use it for anything other than its purpose.

    If it gets in your eyes, rinse it with water immediately.

  • Keep out of the reach of children.

    Keep out of the reach of children.

  • Other Information

    Avoid hot or cold places or in direct sunlight.

  • Directions

    1) Wash your hands and feet with clean foot soap and
    use a towel and dryer to completely remove moisture
    2) After applying this product thickly to the nails or toenails
    you want to use, attach it using a gauze or a disposable
    band to prevent the cream from being lost to the outside.

  • Inactive ingredients

    Water, Petrolatum, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Cetyl Alcohol, Polysorbate 60,
    Beeswax, Aloe Arborescens Leaf Extract, Glyceryl Stearate, Butyrospermum Parkii (Shea)Butter,
    Hyaluronic Acid, Citric Acid, Polylysine, Glycerin

  • Package Label

    74721-0100-1

  • INGREDIENTS AND APPEARANCE
    SSEUG SSAGCREAM 
    xanthium strumarium fruit extract, canavalia gladiata extract cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74721-0100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANAVALIA GLADIATA WHOLE (UNII: 9PHQ0141AL) (CANAVALIA GLADIATA WHOLE - UNII:9PHQ0141AL) CANAVALIA GLADIATA WHOLE5 g  in 100 mL
    XANTHIUM STRUMARIUM FRUIT (UNII: TN770YC17C) (XANTHIUM STRUMARIUM FRUIT - UNII:TN770YC17C) XANTHIUM STRUMARIUM FRUIT10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    WATER (UNII: 059QF0KO0R)  
    POLY-L-LYSINE (30000-70000 MW) (UNII: 0A1V8JTU2M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74721-0100-130 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/22/2022
    Labeler - S-ONE PHARMACEUTICAL INC (694626932)
    Registrant - S-ONE PHARMACEUTICAL INC (694626932)
    Establishment
    NameAddressID/FEIBusiness Operations
    S-ONE PHARMACEUTICAL INC694626932manufacture(74721-0100)