Label: HYLANSON ALCOHOL WIPES 13CMX19CM- alcohol cloth

  • NDC Code(s): 77678-003-01
  • Packager: Hebei Zihan Textile Co., Ltd
  • 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 June 21, 2020

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  • Drug Facts

  • Active Ingredient (in each wipe)

    Alcohol 75%

    Purpose

    Antimicrobial

  • Uses

    • For sanitizing skin.
    • Suitable for hygienic personal care.
  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. If in eyes, flush thoroughly with water.

    In the event of an adverse reaction discontinue use and contact a doctor.

    Keep out of reach of children.

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

  • Directions

    • Open clip-lid and peel back fresh-seal label.
    • Remove moist towels to clean skin as required.
    • Responsibly discard towel once used. Do not flush.
    • Close lid when not in use to keep remaining towels moist.
    • Store in a cool dry place and keep away from heat and direct sunlight.
  • Inactive Ingredients

    Water 24.8%, Glycerin 0.2%.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    HYLANSON ALCOHOL WIPES 13CMX19CM 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77678-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77678-003-01100 in 1 BOX05/28/2020
    12.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/28/2020
    Labeler - Hebei Zihan Textile Co., Ltd (554532773)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hebei Zihan Textile Co., Ltd554532773manufacture(77678-003)
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