Label: DR.CLEANEW HAND SANITIZER- alcohol liquid

  • 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 24, 2020

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

View All Sections
  • PURPOSE

    Antimicrobial

  • Active Ingredients

    ALCOHOL

  • Use

    Hand sanitizer to help reduce bacteria that potentially can cause disease.
    Recommended for external use only.

  • Warnings

    For external use only

    Keep away from fire of flame

    Do not spray on clothes because it can stain.

    Be caeful not to get into your eyes, and if so wash thoroughly with water

  • Keep out of reach of children

    Keep out of reach of children.

  • Stop use and ask a doctor

    Take care not to get into the eye.

    If a children has swallowed it go to the hospital immediately and see a doctor

  • Other information

    beause replacing in other containers can cause accidents or deteriorate quality, put it in the original container and keep

    it tightly closed.

    store away from high temperature and fire.

  • indication

    sprinkle evenly on your hands

  • do not use

    do not use on intraoral, mucosal and damaged skin

    carefully use for the people with allergic reactions,

    immediately discontinue use and consult a dermatologist if hypersensitivity symptoms

    such as rash itching etc occur

    skin irritation symptoms occur

  • inactive ingredient

    water, citric acid

  • Direction

    disinfection of hands and skin

    Spray on hands or spray where disinfection is needed

  • label

    79191-301-01

    79191-301-01

    79191-301-02

    79191-301-02

  • INGREDIENTS AND APPEARANCE
    DR.CLEANEW HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79191-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 39.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79191-301-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/25/2020
    2NDC:79191-301-02500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/25/2020
    Labeler - NR CO.,Ltd. (690430136)
    Registrant - NR CO.,Ltd. (690430136)
    Establishment
    NameAddressID/FEIBusiness Operations
    NR CO.,Ltd.690430136manufacture(79191-301)
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!