Label: SANITIZER- alcohol liquid

  • 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 October 19, 2020

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  • Active Ingredient

    Isopropyl Alcohol 70% v/v

  • Purposes

    Antimicrobial

  • Uses

    Hand sanitizer to decrease virus and bacteria on the skin that could cause disease

    Recommended for repetead use

  • Warnings

    Flammable, keep away form fire or flame

  • For external use only: hands

    For external use only: hands

  • When using this product

    keep out of eyes, do not use in or near eyes.

    In case of contact with eyes, flush thorougly with water

    avoid contact with broken skin

    do not inhale or ingest

  • Stop use or ask a doctor if

    Irritation and redness develop and condition persist for more than 72 hours

  • Keep out of reach of children

    If swallowed, get medical help or contact a poison control center right away

  • Directions

    Put enough product in your palm cover hands and rub hands together briskly until dry without wiping

    for children under 6 years of age should be supervised when using

  • Other information

    Store below 105F (40C)

    may discolour certain fabrics

    harmful to wood finishes and plastics

  • Inactive ingredients

    Purified water (aqua), vegetable glycerine, d-limonene and linalool as fragance

  • Principal Display

    label 100 ml 70% Isopropyl hand sanitizer

    Fresh scent

    with terpene enhaced

    antibacterial protection

    kills 99% of bacteria and germs

    70% isopropyl alcohol

    no ethyl alcohol

    no hudrogen peroxide

    scented with natural terpenes

    helps moisturize with glycerine

    3.4 fluid onces (100 ml)

  • INGREDIENTS AND APPEARANCE
    SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80535-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    WATER (UNII: 059QF0KO0R)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80535-0003-1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/19/2020
    Labeler - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)
    Registrant - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)
    Establishment
    NameAddressID/FEIBusiness Operations
    FARMACIA SAN ARCANGEL, S.A DE C.V951583068label(80535-0003) , manufacture(80535-0003) , pack(80535-0003)
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