Label: TRU AND GEN 75% ALCOHOL WET WIPES- alcohol cloth

  • 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 September 8, 2020

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  • Active Ingredient

    ALCOHOL ---- 75%

    Purpose:

    Antibacterial

  • Inactive Ingredients

    Water, Sodium benzoate, PEG-60 Hydrogenated Castor Oil, Lavandual Angustifolia (Lavender) Oil, Butylene Glycol, Aloe Vera Leaf Extract, Chamomila Recutita (Matricaria) Flower Extract

  • Directions for Use

    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.

  • Warnings:

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

  • When using this product:

    Keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • Uses:

    Hand Sterilization to help reduce bacteria that potentially can cause disease.

  • Keep Out of Reach of Children:

    If swallowed, get medical help or contact a Poison Control Center right way.

  • Other Information:

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

    Keep the lid tightly closed

  • PRINCIPAL DISPLAY PANEL

  • 50 Wipes PDP, NDC: 80500-001-01

    50 Wipes, NDC: 80500-001-01

    50 WIPES PDPPAGE 2

  • INGREDIENTS AND APPEARANCE
    TRU AND GEN 75% ALCOHOL WET WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80500-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 
    Inactive Ingredients
    Ingredient NameStrength
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ROSEMARY (UNII: IJ67X351P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80500-001-0150 in 1 PACKET; Type 0: Not a Combination Product09/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/10/2020
    Labeler - TRU & GEN (117625864)
    Registrant - TRU & GEN (117625864)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRU & GEN LLC117625864pack(80500-001) , label(80500-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONGBANG COSMETICS CO., LTD694452564manufacture(80500-001)
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