Label: AKTIVE SANITIZING WIPES- ethanol alcohol 75% swab

  • 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 25, 2020

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  • Active Ingredient

    Ethanol Alcohol 75%

  • Purpose

    Sanitize

  • Uses

    Sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

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

  • Do not use


    On children less than 2 months old of age

    On open skin wounds

  • When using this product

    Keep out of eyes, ears, 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

    -Wet area thoroughly with wipe. Allow to dry without rinsing.

    -Supervise children under 6 years of age when using this product.

  • Other Information

    Store at room temperature 15-30C (59-86F).

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

  • Inactive Ingredients

    Purified Water

  • Aktive Sanitizing Wipes

    wipes

  • INGREDIENTS AND APPEARANCE
    AKTIVE SANITIZING WIPES 
    ethanol alcohol 75% swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78164-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78164-100-5050 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
    2NDC:78164-100-055 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
    3NDC:78164-100-1010 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
    4NDC:78164-100-2525 in 1 POUCH; Type 0: Not a Combination Product05/01/2020
    5NDC:78164-100-3030 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
    6NDC:78164-100-4040 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
    7NDC:78164-100-7575 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
    8NDC:78164-100-8080 in 1 POUCH; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Gertex Hosiery (201658481)
    Registrant - Gertex Hosiery (201658481)
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