Label: HBA SANITARY WIPES- polihexanide solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 22, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    polyhexamethylene biguanide 0.2% w/w

    Purpose

    Antibacterial

  • Use

    ■ Skin disinfection

  • WARNINGS

    For external use only

    Do not use if you are allergic to any ingredients listed

    Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

    Do not get into eyes. Rinse thoroughly with water if contact occurs

    keep out of reach of children

    Keep out of reach of children. 

  • Directions

    Open the package and close it in time after extraction to keep the product wet and clean. The action time for hands < 1 min, the action time for intact skin and mucous membrane < 5 min, and the action time for ordinary object surface < 30 min

  • Inactive ingredients

    Water, Artemisia argyi levi. et Van, Centella asiatica (i.) Urban, Aloe vera (Haw.) Berg

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HBA SANITARY WIPES 
    polihexanide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79158-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE5.44 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    ARTEMISIA ARGYI WHOLE (UNII: HCK8PG4YA2)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79158-004-0180 in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/22/2020
    Labeler - Henan Huibo Medical Co., Ltd. (560455084)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Huibo Medical Co., Ltd.560455084manufacture(79158-004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!