Label: PURELOGIC HAND SANITIZER FRENCH LAVENDER AND LEMON MINT 6 PACK- alcohol kit

  • 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 1, 2020

If you are a consumer or patient please visit this version.

  • PureLogic Hand Sanitizer French Lavender

    PureLogic Hand Sanitizer French Lavender

    Active Ingredient

    Ethyl Alcohol 63%

    Purpose

    Antimicrobial

  • Use

    ■ Decrease bacteria on the skin that could cause diseases
    ■Recommended for repeated use

  • WARNINGS

    For external use only, Hands

    Flammable. Keep away from flame or fire

    When using this product, keep out of eyes. 
    In case of contact with eyes, flush thoroughly with water

    Avoid contact with broken skin

    Do not inhale or ingest

    Stop Use

    Stop use and ask a doctor if redness and irritation develop or if condition persistes for more than 72 hours

    keep out of reach of children

    Keep out of reach of children. If swalowed, get medical help or contact a poison control center immediately

  • Directions

    Spread product on hands thoroughly and allow to dry, do not wipe off
    For children under 6, use under adult supervision
    Not recommended for use with infants

  • Other information

    Do not store above 105F (40.6C)

    May discolor some fabrics

    Harmful to plastics and wood finishes

  • Inactive ingredients

    Purified water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance, Red 33 (CI17200), Blue 1 (CI42090)

  • PureLogic Hand Sanitizer Lemon Mint

    PureLogic Hand Sanitizer Lemon Mint

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 63%

  • PURPOSE

    Purpose:

    Antimicrobial

  • INDICATIONS & USAGE

    Uses:

    Decrease bacteria on the skin that could cause diseases
    ■Recommended for repeated use

  • Warnings

    For external use on hands only

    Flammable. Keep away from flame or fire

    When using this product, keep out of eyes.
    In case of contact with eyes, flush thoroughly with water

    Avoid contact with broken skin

    Do not inhale or ingest

  • Stop Use

    Stop use and ask a doctor if redness and irritation develop or if condition persistes for more than 72 hours

  • Keep out of reach of children

    Keep out of reach of children. If swalowed, get medical help or contact a poison control center immediately

  • Directions

    Spread product on hands thoroughly and allow to dry, do not wipe off
    For children under 6, use under adult supervision
    Not recommended for use with infants

  • Other Information

    Do not store above 105F (40.6C)

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive Ingredients

    Purified water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance, Yellow 5 (CI19140)

  • Kit Box

    image description

  • French Lavender

    image description

  • Lemon Mint

    image description

  • INGREDIENTS AND APPEARANCE
    PURELOGIC HAND SANITIZER FRENCH LAVENDER AND LEMON MINT 6 PACK 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77731-048
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77731-048-011 in 1 BOX; Type 1: Convenience Kit of Co-Package07/31/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 113 BOTTLE 768 mL
    Part 213 BOTTLE 768 mL
    Part 1 of 2
    PURELOGIC HAND SANITIZER FRENCH LAVENDER 
    alcohol solution
    Product Information
    Item Code (Source)NDC:77731-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77731-046-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:77731-046-022 in 1 PACKAGE
    2354 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2020
    Part 2 of 2
    PURELOGIC HAND SANITIZER LEMON MINT 
    alcohol solution
    Product Information
    Item Code (Source)NDC:77731-047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77731-047-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:77731-047-022 in 1 PACKAGE
    2354 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2020
    Labeler - Argento sc by sicura inc. (168718778)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Roni Cosmetic Co., Ltd411892769manufacture(77731-048, 77731-046, 77731-047)