Label: DR SAFE HAND SANITIZING WIPES- 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 February 11, 2021

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  • DRUG FACTS

  • Active ingredient

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • Uses

    Hand Sanitizing Wipes 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 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

    • Wet hands thoroughly with product and allow to dry without wiping

    • Do not flush

    • Children under 2 years ask a doctor before use

  • Other information

    • Read the directions and warnings before use

    • Store between 15-30°C (59-89°F)

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

  • Inactive ingredient: 

    Purified Water.

  • SPL UNCLASSIFIED SECTION

    * Kills 99% of common germs

    * Antibacterial

    * Cleans instantly without water

    Manufactured for:

    S.P.M CORPORATION

    www.spm.com.vn

    Lot 51, Street 2, Tan Tao Industrial Park, Tan Tao A Ward,

    Binh Tan District, Ho Chi Minh City, Vietnam.

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    DR SAFE HAND SANITIZING WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78898-775
    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:78898-775-1010 in 1 PACKET02/06/2021
    13.6 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:78898-775-2020 in 1 PACKET02/06/2021
    23.6 mL in 1 PATCH; Type 0: Not a Combination Product
    3NDC:78898-775-6060 in 1 PACKET02/06/2021
    34.2 mL in 1 PATCH; Type 0: Not a Combination Product
    4NDC:78898-775-8080 in 1 PACKET02/06/2021
    44.2 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 finalpart333A02/06/2021
    Labeler - Eco Wipes Vietnam Corporation (557278721)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eco Wipes Vietnam Corporation557278721manufacture(78898-775)
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