Label: FRESH FARMS DEEP MOISTURIZING HAND SANITIZER- isopropyl 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 May 18, 2020

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  • Drug Facts

  • Active Ingredients

    Isoprpyl Alcohol 75%

  • Purpose

    Antimicrobial

  • DOSAGE & ADMINISTRATION

    Directions:Put a thumbnail size amount in your palm and rub your hands together briskly until dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients:Water, Essential Oils, Carbomer, Triethanolamine.

  • WARNINGS

    WARNING: Flammable. Keep away from flame. Keep out of eyes. In case of eye contact immediately flush eyes with water then contact physician. If swallowed, contact physician.

    For External Use only. Do not store above 110F.

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Use :  to decrease bacteria on the skin that could cause disease.

  • SPL UNCLASSIFIED SECTION

    DEEP MOISTURIZING

    KILLS 99.9% OF GERMS

    UNSCENTED

    Infused with Argan Oil and All Natural Essential Oils

    Kills Over 99% of the most common germs within seconds, and moisturizes your hands! Use as an aid to reduce exposure to infectious germs.

    MADE IN THE USA

    DISTRIBUTED BY

    Fresh Farms, LLC

    WWW.FRESHFARMS.SHOP

    (855) 5 FRESH 5

    SHAKE WELL

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    FRESH FARMS DEEP MOISTURIZING HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78215-421
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78215-421-55120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/30/2020
    Labeler - Fresh Farms Llc (113105850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fresh Farms Llc113105850manufacture(78215-421)
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