Label: FRESH PROTECT HAND SANITIZER BERGAMONT LIME- 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 August 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Fresh Protect Gel Scented

    Drug Facts

  • Active Ingredients

    Ethyl Alcohol 80% v/v

  • Purpose

    Antimicrobial

  • Uses

    - hand sanitizing to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Do not drink.

    Flammable. Keep away from heat and flame

    Do not use

    on children less than 2 years of age. - on open skin wounds

    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.

  • Directions

    - Place enough product on hands to cover all surfaces - supervised children under 6 years of age when using this product to avoid swallowing.

  • Other information

    - store at 15C to 30C (59F to 86F) - Avoid freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    Water, Ammonium Acryloyldimethltaurate/VP Copolymer, Citrus Sinensis Peel Oil expressed, Citrus Aurantium Bergamia (Bergamot Peel Oil, Citrus Aurantifolia (Lime) Oil, Aloe Barbadensis Leaf Juice, Niacinamide, Hydrogen Peroxide, Maltodextrin, Tocopheryl Acetate, DL-Panthenol

  • PRINCIPAL DISPLAY PANEL

    Fresh
    PROTECT
    HAND SANITIZER GEL
    80% ALCOHOL
    Non-sterile solution

    PRINCIPAL DISPLAY PANEL Fresh PROTECT HAND SANITIZER GEL 80% ALCOHOL Non-sterile solution

  • INGREDIENTS AND APPEARANCE
    FRESH PROTECT HAND SANITIZER  BERGAMONT LIME
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69243-0110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LIME OIL (UNII: UZH29XGA8G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLIME (Bergamot Lime) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69243-0110-159 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
    2NDC:69243-0110-2118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
    3NDC:69243-0110-3237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
    4NDC:69243-0110-4355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
    5NDC:69243-0110-5473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
    6NDC:69243-0110-6946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
    7NDC:69243-0110-71893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
    8NDC:69243-0110-83785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35608/13/2020
    Labeler - Willspeed Technologies LLC (019063540)
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