Label: FRESHWORKS ANTISEPTIC HAND SANITIZER LAVENDER FIELDS FRAGRANCE- 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 December 8, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 65% 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

    0,30% Carbomer 940 0.50% Aloe Vera Juice 0,50% Glycerine 0,20% Fragrance 0,03% Vitamin E 0,3 % TEA

  • Questions?

    +1-833-451-1635 You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

  • Package Labeling:50ml

    bottle7

  • Package Labeling:100ml

    BOttle8

  • Package Labeling:250ml

    Bottle9

  • INGREDIENTS AND APPEARANCE
    FRESHWORKS ANTISEPTIC HAND SANITIZER LAVENDER FIELDS FRAGRANCE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80890-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.65 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TEA LEAF (UNII: GH42T47V24)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80890-002-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2020
    2NDC:80890-002-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2020
    3NDC:80890-002-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/04/2020
    Labeler - Envelope Group, LLC (833284370)
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