Label: CLEENSCENT HAND SANITIZER GEL- isopropyl 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 August 4, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (84 FR 14847) (effective April 12, 2020).

    The hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product, with percentages iof the active ingredient consistent with the above mentioned final rule, Isopropyl Alcohol (70%, v/v).

  • ACTIVE INGREDIENT

    Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

  • PURPOSE

    Hand Sanitizer

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame

  • DO NOT USE

    -in children less than 2 months of age
    -on open skin wounds

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Place enough product on hands to cover all surfaces. Rub hands together until dry.
    Supervise children under 6 years of age when using this product to avoid swallowing.

  • STORAGE AND HANDLING

    -Store between 15-30C (59-86F)
    -Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    glycerin, purified water USP, carbomer, trolamine

  • PRINCIPAL DISPLAY PANEL

    Front and back label for CllenScent Hand Sanitizer Gel 60 ml60 ml NDC: 78108-1704-2

  • INGREDIENTS AND APPEARANCE
    CLEENSCENT HAND SANITIZER GEL 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78108-1704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.3 g  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78108-1704-260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/04/2020
    Labeler - XMA Servicios de Manufactura S de RL de CV (951577310)
    Establishment
    NameAddressID/FEIBusiness Operations
    XMA Servicios de Manufactura S de RL de CV951577310manufacture(78108-1704)
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