Label: KLEANOPS- 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 October 21, 2021

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

View All Sections
  • Active Ingredient

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on skin.

  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame.

    Do not use
    • On open skin wound.
    • On children less than 2 months of age.

    When using this product keep out of eyes. In case of contact, rinse eyes with water.

    Stop use and ask a doctor if irritation or rash appears.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Wipe hands thoroughly with product and allow to dry.
    • Children under 6 years of age must be supervised when using this product.
  • OTHER INFORMATION


    • Store below 40°C (104°F).
    • May discolor certain fabric.

  • Inactive ingredients

    Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Isopropyl Myristate, Tocopheryl Acetate

  • Package Label - Principal Display Panel

    Label 1

    Label 2

    Label 3

  • INGREDIENTS AND APPEARANCE
    KLEANOPS 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79912-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79912-001-0120 in 1 BOX08/01/2020
    11 in 1 PACKAGE
    12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:79912-001-0220 in 1 POUCH08/01/2020
    21 in 1 PACKAGE
    22 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:79912-001-0380 in 1 CONTAINER08/01/2020
    31 in 1 PACKAGE
    32 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - KLEANOPS LLC (117552751)
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!