Label: ALCOHOL WIPES LEMON SCENT- ethyl 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 November 14, 2020

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  • Active Ingredients

    Ethyl Alcohol 80%

  • Purpose

    Antimicrobial

  • Uses

    Alcohol Wipes are used to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Keep away from heat or flame.

  • Do not use

    • in children less than 2 years of age, do not use as baby wipe.
    • 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

    • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole in cover. Keep lid closed to prevent moisture loss.
    • Open and unfold wipe.
    • Thoroughly wipe hands, fingers, and wrists. Be sure to use the entire wipe. Allow to dry.
    • For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with the second wipe.
    • Discard after single use.
    • Supervise children under 2 years of age when using this product to avoid swallowing.
  • Other information

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

    Water (aqua), hydrogen peroxide, glycerin, aloe barbadensis (aloe vera) leaf juice, lemon fragrance (parfum)

  • Package Label

    Alcohol Wipes Lemon Scent, 80 wipes, 454ml, NDC: 76523-002-80

    Label Product picture Front

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES LEMON SCENT 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76523-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.3 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 0.2 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 17.93 mL  in 100 mL
    Product Characteristics
    Colorwhite (White canister with blue cap) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76523-002-80454 mL in 1 CANISTER; Type 0: Not a Combination Product11/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/14/2020
    Labeler - Valley of the Sun Cosmetics LLC (176470664)
    Registrant - Valley of the Sun Cosmetics LLC (176470664)
    Establishment
    NameAddressID/FEIBusiness Operations
    Valley of the Sun Cosmetics LLC176470664manufacture(76523-002)
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