Label: ISSEEY - MOISTURIZING HAND SANITIZER - LEMON- ethyl alcohol gel

  • 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 September 17, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 75%

  • 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 gel into 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

    Do not store above 105°F

    ■ may discolor some fabrics.

  • Inactive ingredients

    Purified Water, Glycerinum, Carbomer, Triethanolamine, Lemon Fragrance, FD&C Blue1.

  • SPL UNCLASSIFIED SECTION

    Fresh Lemon

    KILLS 99.99% OF GERMS

    CAUTIONS: DO NOT DRINK. THIS PRODUCT IS FOR EXTERNAL USE ONLY. PLEASE KEEP IT IN A COOL PLACE, AWAY FROM DIRECT

    SUNLIGHT AND FIRE

    Distributed By

    ISSEEY TM

    P.O. Box 2015

    Alief, TX - 77411

    Questions?

    info.isseey@gmail.com

    www.isseey.com

    MADE IN CHINA

    Best used before by:

    Marked on the bottom

  • Packaging

    IMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    ISSEEY - MOISTURIZING HAND SANITIZER - LEMON 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80568-475
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LEMON OIL (UNII: I9GRO824LL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80568-475-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
    2NDC:80568-475-10300 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
    3NDC:80568-475-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/17/2020
    Labeler - ISSEEY (117606552)
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