Label: LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 16 OZ- alcohol liquid
LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 128 OZ/ 1 GALLON- alcohol liquid
LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 8 OZ- alcohol liquid

  • 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 May 5, 2020

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  • SPL UNCLASSIFIED SECTION

    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)

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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. Sterile distilled water (26.5% v/v).
    3. Aloe Barbadensis Leaf liquid (3.2% v/v).
    4. Tea Tree Oil (0.3% v/v)

  • Active Ingredient(s)

    Alcohol 70% 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

    Aloe Barbadensis Leaf liquid, Tea Tree Oil, purified water USP

  • Package Label - Principal Display Panel

    236 mL NDC: 77179-7008-1 236ml Label

    473 mL NDC: 77179-7016-2 473 mL NDC: 77179-7016-2

    3785 mL NDC: 77179-7128-4 3785 mL NDC: 77179-7128-4

  • INGREDIENTS AND APPEARANCE
    LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 16 OZ 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77179-7016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL473 mL  in 473 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 473 mL  in 473 mL
    TEA TREE OIL (UNII: VIF565UC2G) 473 mL  in 473 mL
    WATER (UNII: 059QF0KO0R) 473 mL  in 473 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77179-7016-2473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/12/2020
    LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 128 OZ/ 1 GALLON 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77179-7128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3785 mL  in 3785 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 3785 mL  in 3785 mL
    TEA TREE OIL (UNII: VIF565UC2G) 3785 mL  in 3785 mL
    WATER (UNII: 059QF0KO0R) 3785 mL  in 3785 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77179-7128-43785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/12/2020
    LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 8 OZ 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77179-7008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL236 mL  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 236 mL  in 236 mL
    TEA TREE OIL (UNII: VIF565UC2G) 236 mL  in 236 mL
    WATER (UNII: 059QF0KO0R) 236 mL  in 236 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77179-7008-1236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/12/2020
    Labeler - Y. SA, INC (080269381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Y. SA, INC080269381manufacture(77179-7008, 77179-7016, 77179-7128)
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