Label: 75% ALCOHOL WIPES 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 9, 2020

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  • Active Ingredient(s)

    75% Alcohol

  • Purpose

    Antiseptic

  • Use

    For hand sanitizing that helps reduce bacteria on the skin, recommended for repeated use.

  • Warnings

    • For external use only.
    • Highly Flammable - Keep away from fire or flame.
  • Do not use

    • On open skin wounds.
  • WHEN USING

    • Avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush with water.
    • Avoid contact with broken skin. Do not inhale or ingest.
  • STOP USE

    Stop use and ask a doctor if skin irritation or rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact a Poison Control Center or a doctor.

  • Directions

    • Wipe hands, discard properly in trash receptacle.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store at room temperature. Do not store above 105℉.
    • Do not freeze
    • May discolor some fabrics. Harmful to wood finishes and plastics.
    • Effective at eliminating more than 99.99% of many common harmful germs and bacteriain as little as 15 seconds.
  • Inactive ingredients

    high-quality spunlace non-woven fabric, Water.

  • Package Label - Principal Display Panel

    5pcs NDC: 55676-002-01

    10pcs NDC: 55676-002-02

    40pcs NDC: 55676-002-03

    50pcs NDC: 55676-002-04 50pcs label

    80pcs NDC: 55676-002-05

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL WIPES 
    75% alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55676-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55676-002-015 in 1 PACKET09/09/2020
    14.05 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:55676-002-0210 in 1 PACKET09/09/2020
    23.57 mL in 1 PATCH; Type 0: Not a Combination Product
    3NDC:55676-002-0340 in 1 PACKET09/09/2020
    35.36 mL in 1 PATCH; Type 0: Not a Combination Product
    4NDC:55676-002-0450 in 1 PACKET09/09/2020
    45.71 mL in 1 PATCH; Type 0: Not a Combination Product
    5NDC:55676-002-0580 in 1 PACKET09/09/2020
    54.46 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/09/2020
    Labeler - SHANDONG HELI DAILY NECESSITIES CO.,LTD (554547329)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANDONG HELI DAILY NECESSITIES CO.,LTD554547329manufacture(55676-002)
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