Label: 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 January 7, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% V/V

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    For external use only. Flammable

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thorougly with water.

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

    • Stop use and ask a doctor if irritation or redness develops and lasts more than 72 hours.
  • Directions

    Put enough product in your hand palm and rub hands together until dry.

  • Other Information

    • Do not store above 105 ºF (40 ºC).
  • Inactive Ingredients

    Aqua (Water), Glycerin, Carbomer, Aloe Barbadensis Extract, Triethanolamine, Methylisothiazolinone (and) Iodopropynil Butil Carbamate.

  • Questions?

    M-F: 8-5 CT

    +1 781 519-4494

  • SPL UNCLASSIFIED SECTION

    Manufactured in Honduras by Industrias Chamer S.A.
    P.O. Box 31263, 2227 NW 79th Ave; Doral, Fla. 33198

  • PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

    Puriderm™

    HAND SANITIZER
    ANTIBACTERIAL

    KILLS 99.99% OF GERMS

    70% ETHYL ALCOHOL

    WITH ALOE VERA AND GLYCERIN
    SOFT ON THE SKIN

    ℮ 16 FL OZ (480 mL)

    Principal Display Panel - 480 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51774-001
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51774-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC:51774-001-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    3NDC:51774-001-05120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    4NDC:51774-001-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    5NDC:51774-001-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    6NDC:51774-001-341000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    7NDC:51774-001-641893 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    8NDC:51774-001-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    9NDC:51774-001-12360 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Industrias Chamer Sa De Cv (850602483)
    Establishment
    NameAddressID/FEIBusiness Operations
    Industrias Chamer Sa De Cv850602483MANUFACTURE(51774-001)