Label: AIWINA WET WIPES- benzalkonium chloride 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 August 7, 2020

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  • Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.10%

  • Purpose

    Antiseptic

  • Uses

    • For hand washing to decrease bacteria on the skin. Recommended for repeated use.

  • 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 one 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.

  • 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), Glycerol, Propanediol, Aloe Vera Extract, Amino acid moisturizer, Hexadecylpyridinium Chloride, Chlorphenesin, Vitamin E, Citric acid, Sodium citrate.

  • SPL UNCLASSIFIED SECTION

    NEW!

    Recyclable Packaging

    Gently Cleansing

    PREMIUM  Aloe Vera  Vitamin E WIPES

    SAFE FOR SENSITIVE SKIN     ALCOHOL FREE

    Over 99% Water

    SHEET SIZE 20X15 CM

    DO NOT MACER

    Do not flush

    CERTIFIED ISO 9001:2008 COMPANY

    SYSTEM CERTIFICATION ISO 9001:2008 SGS

    MANUFACTURER:

    DOBOLV (QUANZHOU)PAPER CO., LTD

    FuMaolin Development Zone, Shengxin Town,

    Nan'an City.

    www.aiwina.com

    info@aiwina.com

    Made in China

    INSTANT RESULT

    NO WATER/ TOWELS

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    AIWINA WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79891-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BETAINE (UNII: 3SCV180C9W)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79891-001-5080 in 1 BAG08/10/2020
    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 finalpart333A08/10/2020
    Labeler - DOBOLV (QUANZHOU) PAPER CO., LTD (550022046)
    Establishment
    NameAddressID/FEIBusiness Operations
    DOBOLV (QUANZHOU) PAPER CO., LTD550022046manufacture(79891-001)
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