Label: SEAL NON ALCOHOL BASED HAND SANITIZER- benzalkonium chloride 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 May 21, 2020

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  • Drug Facts

  • PURPOSE

    Purpose: Antiseptic

  • ACTIVE INGREDIENTS

    Component

    Benzalkonium chloride - 0.5 %

  • INACTIVE INGREDIENTS

    Boro Glycerine, Carbomer, Triethanolamine, Methyl salicylate, Water, Citric acid, Vitamine E.

  • INDICATIONS & USAGE

    Use: Hand Sanitizer to help reduce microbes that potentially can cause disease. For use when soap and water are not available

  • WARNINGS

    When using this product: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor: if irritation occurs, please consult a doctor.

    Do not use

    • In children less than 2 months of age

    • On open skin wounds.

    Warning

    • For external use only

    • Keep out of Reach of Children

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.

    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    • Store between 15-30°C (59-86F)

    • Avoid freezing and excessive heat above 40°C (104F)

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Atlantic Care Chemicals. Pvt. Ltd
    Industrial Development Plot,
    Alappuzha, Kerala, India.

    9001:2015

    ISO CERTIFIED COMPANY

    PASSION FOR INNOVATION

    care@atlanticchemicals.com
    www.atlanticchemicals.com

    MADE IN INDIA

  • Packaging

    Seal2

  • INGREDIENTS AND APPEARANCE
    SEAL NON ALCOHOL BASED HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77249-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    BOROGLYCERIN (UNII: U3LMU4AN21)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77249-104-455 L in 1 CAN; Type 0: Not a Combination Product05/15/2020
    2NDC:77249-104-010.1 L in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    3NDC:77249-104-020.2 L in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    4NDC:77249-104-050.5 L in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2020
    Labeler - ATLANTIC CARE CHEMICALS PRIVATE LIMITED (861499902)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC CARE CHEMICALS PRIVATE LIMITED861499902manufacture(77249-104)
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