Label: HYGIENEX LINEN BREEZE HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 August 11, 2020

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  • Active Ingredient(s)

    Alcohol 72% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

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

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    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 or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

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

    glycerin, water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, AMP, Tocopherol Acetate, Fragrance(s)

  • Package Label - Principal Display Panel

    HGXLBGel1GLabel

    1 Gallon NDC: 74588-795-04

    HGXLBGel5GLabel

    5 Gallon NDC: 74588-795-05

    HGXLBGel55GLabel

    55 Gallon NDC: 74588-795-01

    HGXLBGel275GLabel

    275 Gallon NDC: 74588-795-02

    HGXLBGel330GLabel

    330 Gallon NDC: 74588-795-03

    HGXLBGel16ozLabel

    16 Oz NDC: 74588-795-11

    HGXLBGel32ozLabel

    32 Oz NDC: 74588-795-12

    HGXLBGel64ozLabel

    64 Oz NDC: 74588-795-13

  • INGREDIENTS AND APPEARANCE
    HYGIENEX LINEN BREEZE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74588-795
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74588-795-043785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:74588-795-12946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:74588-795-11473.176 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:74588-795-0518927 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    5NDC:74588-795-01208198 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    6NDC:74588-795-021040990 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
    7NDC:74588-795-031249190 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
    8NDC:74588-795-131890 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Global Impact Innovation LLC (117465830)
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