Label: AIWINA SANITIZING WET WIPES- 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 September 29, 2020

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  • Drug Facts

  • Active ingredients

    Alcohol 75%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses For hand washing to decrease bacteria on the skin. Recommended for repeat use.

  • WARNINGS

    Warnings For external use only.

    Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.

    Do not use if you are allergic to any of the ingredients.

    Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

    Keep out of reach of children unless under adult supervision.

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

    keep out of reach of fire.

  • Directions of use

    Open resealable label and pull one sheet from pack. Thoroughly clean hands or affected area and discard in receptacle, and do not flush. Allow to dry without wiping. Be sure to reseal label complete to retain moisture.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Water (Aqua), Glycerine, Lemon Extract, Vitamin E, Phenoxyethanol, Betaine, Benzalkonium Chloride.

  • SPL UNCLASSIFIED SECTION

    EXTRA SOFT

    75% ALCOHOL 

    100% NATURAL

    with lemon extract

    PH > 7

    alcohol

    PASSED SKIN IRRITATION TEST

    Anti-bacterial

    Best Quality GUARANTEED

    ISO 9001:2008 CERTIFIED COMPANY

    SYSTEM CERTIFICATION ISO 9001:2000

    SGS

    Recyclable Packaging

    Made in P.R.C

    QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD

    NO.5, FULONG SOUTH ROAD, YOUYUAN VILLAGE, SHENGXIN TOWN, NAN'AN CITY,

    QUANZHOU CITY, FUJIAN, CHINA

    www.aiwina.com.

    info@aiwina.com

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    AIWINA SANITIZING WET WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80671-001
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEMON (UNII: 24RS0A988O)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BETAINE (UNII: 3SCV180C9W)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80671-001-5050 in 1 BAG09/10/2020
    14 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/10/2020
    Labeler - QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD (554548985)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD554548985manufacture(80671-001)
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