Label: LEAFREE HAND SANITIZER ALOE VERA 16.91OZ- ethyl alcohol gel
LEAFREE HAND SANITIZER ALOE VERA 3.38 OZ- ethyl alcohol gel
LEAFREE HAND SANITIZER ALOE VERA 10.14OZ- ethyl 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 April 25, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Carbomer (0.24% v/v).
    3. Triethanolamine (0.2% v/v).
    4. Sterile distilled water or boiled cold water.
    5. ALOE VERA.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 70% v/v Alcohol 70% v/v. Purpose: ANTIMICROBIAL

  • Purpose

    LabelAntiseptic, Hand Sanitizer

  • Use

    LabelHand 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

  • Warnings:

    • in children less than 2 months of age
    • on open skin wounds
      Warnings
  • 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.
    • Use as needed. No need to rinse with water.
    • Supervise children under 6 years of age when using this product to avoid swallowing and should be supervised by an adult.
  • Other information

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

    Carbomer, Triethanolamine, Aloe Vera, Water

  • Package Label - Principal Display Panel

    100 mL NDC: 76573-160-18

    300 ml NDC: 76573-370-05

    500 ml NDC: 76573-530-09 500ml ALOE VERA300ml ALOE VERA100ml ALOE VERA

  • INGREDIENTS AND APPEARANCE
    LEAFREE HAND SANITIZER ALOE VERA 16.91OZ 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76573-530
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 100 mL
    CARBOMER 1342 (UNII: 809Y72KV36) 0.24 mL  in 100 mL
    CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E) 0.2 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.06 mL  in 100 mL
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76573-530-09500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    LEAFREE HAND SANITIZER ALOE VERA 3.38 OZ 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76573-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 1342 (UNII: 809Y72KV36) 0.24 mL  in 100 mL
    CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E) 0.2 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.06 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 100 mL
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76573-160-18100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    LEAFREE HAND SANITIZER ALOE VERA 10.14OZ 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76573-370
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 100 mL
    CARBOMER 1342 (UNII: 809Y72KV36) 0.24 mL  in 100 mL
    CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E) 0.2 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.06 mL  in 100 mL
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76573-370-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Corgiomed,LLC (117502701)
    Registrant - Corgiomed,LLC (117502701)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Olande Cosmetic Co., Ltd529466827manufacture(76573-160, 76573-370, 76573-530)
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