Label: BESAFE HAND SANITIZER- alcohol solution

  • 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 July 14, 2020

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacterial on the skin

  • Warnings

    For external use only. Flammable. Keep away from fire and flame.

  • WHEN USING

    Do not use in the eyes

  • STOP USE

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more then 72 hours
  • 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.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping

    For children under 6, use only under adults supervision

    Not reommended for infants

  • Other information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Water, carbomer, triethanolamine, glycerin, aloe barbadensis gel, propylene glycol, tocopheryl acetate (Vitamin E)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BESAFE HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77693-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77693-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    2NDC:77693-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    3NDC:77693-001-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    4NDC:77693-001-04237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    5NDC:77693-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    6NDC:77693-001-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    7NDC:77693-001-071800 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    8NDC:77693-001-083780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/14/2020
    Labeler - Besafe Industries LLC (117481216)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch414137820manufacture(77693-001)
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