Label: SIGNATURE ALCOHOL FOAMING HAND 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 March 8, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl alcohol 62%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to decrease bacteria on the skin

    Recommended for repeated use

  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flames.

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    Wash hands with soap and water

    Rinse with potable water

    Pump a small amount of foam into palm of hand

    Rub thoroughly over all surfaces of both hands

    Rub hands together briskly until dry

  • STORAGE AND HANDLING

    Other Information:

    Store below 110 F (43 C)

    May discolor certain fabrics or surfaces

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    DEA-C8-18 perfluoroalkylethyl phosphate, Glycerin, Isopropyl alcohol, Water

  • PRINCIPAL DISPLAY PANEL

    Cintas

    Signature Series

    Alcohol Foaming

    Hand Sanitizer

    50 ML/1.7 FL OZ

    Sample - Not for Resale

    container label

  • INGREDIENTS AND APPEARANCE
    SIGNATURE ALCOHOL FOAMING HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-013
    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
    DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-013-0650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:42961-013-05500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2015
    Labeler - Cintas Corp. (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Essentials Incorporated947484713manufacture(42961-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avmor202107827manufacture(42961-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc627278224manufacture(42961-013)
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