Label: BIORESTORE HAND SANITIZING WIPES- ethyl alcohol cloth

  • 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 14, 2021

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  • Active Ingredient(s)

    Ethanol Alcohol 70% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial

  • Use

    Antiseptic skin cleanser, Kills harmful bacteria

  • Warnings

    • For external use only.
    • Keep away from fire or flame
  • When using

    When using this product keep out of eyes. If contact with eyes occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • Do not use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Wipe thoroughly into hands for atleast 30 seconds. Allow to dry.
    • Children under 6 years of age should be supervised when using product.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water, Fragrance, Isopropyl alcohol, glycerin, denatonium benzoate

  • Package Label - Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    BIORESTORE HAND SANITIZING WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78489-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78489-003-8080 in 1 CONTAINER; Type 0: Not a Combination Product01/14/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/14/2021
    Labeler - UNIVERSAL CONSUMER BRANDS INC (246799600)
    Registrant - UNIVERSAL CONSUMER BRANDS INC (246799600)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIVERSAL CONSUMER BRANDS INC246799600manufacture(78489-003)
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