Label: PFA STRONGHOLD SANITIZING HANDLOTION SHEA BUTTER- alcohol lotion

  • NDC Code(s): 80969-007-01
  • Packager: STRONGHOLD TRADING LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated January 25, 2023

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  • Active ingredient

    Alcohol 62%

  • Purpose

    Sanitizer

  • Use

    Hand sanitizing to help reduce bacteria on the skin.

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

  • When using this product

    avoid contact with the eyes.

    In case of contact, flush eyes thoroughly with water.

  • Stop use and ask a doctor

    if irritation and redness develops and persists.

  • Keep out of reach of children.

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

  • Directions

    • Put enough product in the palm to cover hands & rub together briskly the liquid is dry
    • Children under 6 should be supervised when using Sanitizers.
  • Other information

    • Store below 77°F (25°C)
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, PEG-60 Hydrogenated Castor Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Ammonium Polyacryloyldimethyl Taurate, Caprylic/Capric Triglyceride, Centella Asiatica Extract, Cocos Nucifera (Coconut) Oil, Polysorbate 80, Fragrance, Benzyl Salicylate, Coumarin, Limonene, Linalool

  • Package Label

    80969-007-01

  • INGREDIENTS AND APPEARANCE
    PFA STRONGHOLD SANITIZING HANDLOTION SHEA BUTTER 
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80969-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80969-007-012 mL in 1 POUCH; Type 0: Not a Combination Product11/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/26/2021
    Labeler - STRONGHOLD TRADING LLC (117694134)
    Registrant - S-ONE PHARMACEUTICAL INC (694626932)
    Establishment
    NameAddressID/FEIBusiness Operations
    S-ONE PHARMACEUTICAL INC694626932manufacture(80969-007)
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