Label: FRIDA 70 ALCOHOL PLUS ALOE HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 3, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    Flammable: Do not use near hear, flame or while smoking.

    When using this product: Keep put of eyer. If product gets into eyes, rinse with water to remove. Avoid contact with broken skin. Do not inhale or ingest.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center inmediately.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • For children under 6, use only under adult supervision.
  • Other Information

    • Do not store above 104 °F.
    • May discolor some fabrics, wood finishes and plastics.
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Glycerin, Isopropyl Myristate, Tocopherol, Water

  • Questions and comments

    fussbuster@frida.com

  • Frida Hand Sanity 70% Alcohol + Aloe Hand Sanitizer

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    FRIDA  70 ALCOHOL PLUS ALOE HAND SANITIZER
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (Colorless) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0310-3118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/27/2020
    Labeler - Prime Enterprises (101946028)
    Registrant - Prime Enterprises (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises101946028manufacture(58443-0310) , pack(58443-0310) , label(58443-0310) , analysis(58443-0310)
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