Label: PALMIST ANTISEPTIC HAND SANITIZER- ethyl 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 October 27, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame
    For external use only

    Do not use • in children less than 2 months of age • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    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.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    benzalkonium chloride, carbomer, holy basil (Ocimum tenuiflorum), lemon (Citrus medica limonum) oil, neem (Azadirachta indica) leaf extract, triethanolamine, water

  • Questions?

    +1-412-999-4501

    You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Distributed by: LSM DISTRIBUTION LLC.
    312 WEST 7th AVENUE, WEST HOMESTEAD, PA 15120

    MADE IN INDIA

    Ismdistributionllc@gmail.com

    www.palmist.net

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    PALMIST ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80636-101
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    LEMON OIL (UNII: I9GRO824LL)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80636-101-0130 in 1 BOX09/25/2020
    11 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:80636-101-20200 in 1 BAG09/25/2020
    21 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:80636-101-4530 in 1 BOX09/25/2020
    31.5 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:80636-101-30200 in 1 BAG09/25/2020
    41.5 mL in 1 PACKET; Type 0: Not a Combination Product
    5NDC:80636-101-6030 in 1 BOX09/25/2020
    52 mL in 1 PACKET; Type 0: Not a Combination Product
    6NDC:80636-101-40200 in 1 BAG09/25/2020
    62 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/25/2020
    Labeler - POCKET INC (857979919)
    Establishment
    NameAddressID/FEIBusiness Operations
    POCKET INC857979919manufacture(80636-101)
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