Label: ISSEEY - MIST HAND SANITIZER - OVER THE MOON- ethyl 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 January 12, 2021

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

View All Sections
  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 60%

  • Purpose

    Antiseptic

  • Uses

    • Apply on hand to decrease bacteria on the skin that may cause disease • recommended for repeated use.

  • Warnings

    For external use only: hands.

    Flammable, keep away from fire or flame.

    When using this product • keep out of eye, In case of contact with eyes, flush thoroughly with water • avoid contact with broken skin • do not inhale or ingest.

    Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours.

    Keep out of reach of children • if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Use enough amount of product in your palm and thoroughly spread on both hands. rub into skin and allow to dry • for children under 6, must use under adult supervision. • not recommended for infants use.

  • Other information

    • Keep it in a cool place • away from direct sunlight and fire • Do not store above 104°F • may discolor some fabrics.

  • Inactive ingredients

    Purified Water, Glycereth 26, Fragrance, FD&C: (Red 40, Green 3, Blue 2).

  • SPL UNCLASSIFIED SECTION

    Distributed By: ISSEEY™, P.O.Box 2015, Alief, TX - 77411
    For Questions? Email: info.isseey@gmail.com, Web: www.isseey.com

    FRENCH LAVENDER SCENTED    • MADE IN CHINA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ISSEEY - MIST HAND SANITIZER - OVER THE MOON 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80568-657
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80568-657-301 in 1 BOX01/10/2021
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/10/2021
    Labeler - ISSEEY (117606552)
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!