Label: ADVANCED HAND SANITIZER- 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 22, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: Ethyl Alcohol 62%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water/Aqua/Eau, Glycerin, Carbomer, 1,2-Hexanediol, Apium Graveolens (Celery) Extract, Daucus Carota Sativa (Carrot) Root Extract, Foeniculum Vulgare (Fennel) Seed Extract, Brassica Oleracea Acephala Leaf Extract, Coriandrum Sativum (Coriander) Extract, Lactuca Scariola Sativa (Lettuce) Leaf Extract, Spinacia Oleracea (Spinach) Leaf Extract

  • PURPOSE

    Purpose: Antiseptic

  • WARNINGS

    Warnings:
    For external use only : hands
    Flammable, keep away from fire or flame.
    When using this product ■ keep out of eyes. In case of contact with eyes, flush thoroughly with water. ■ avoid contact with broken skin. ■ do not inhale or ingest
    Stop use and ask a doctor if ■irritation and redness develop ■ condition persists for more than 72 hours
    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Uses:
    ■ for handwashing to decrease the bacteria on the skin
    ■ recommended for repeated use

  • Directions

    Directions:

    ■ Apply enough amount into palm and spread on both hands. rub into skin until dry.

    ■ for children under 6, use only under adult supervision

    ■ not recommended for infants

  • Other information

    Other information


    ■ do not store above 105℉

    ■ may discolor some fabrics

    ■ harmful to wood finishes and plastics

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75585-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL310 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    CELERY (UNII: 44IDY6DTKX)  
    CARROT (UNII: L56Z1JK48B)  
    FENNEL SEED (UNII: G3QC02NIE6)  
    KALE (UNII: 0Y3L4J38H1)  
    CORIANDER (UNII: 1OV56052IK)  
    LETTUCE (UNII: 5PO6NN3RRJ)  
    SPINACH (UNII: 6WO75C6WVB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75585-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - Pro's Choice Beauty Care, Inc. (015441970)
    Registrant - Pro's Choice Beauty Care, Inc. (015441970)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(75585-010)
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