Label: CLEANSE PURE- alcohol solution

  • NDC Code(s): 77031-505-01, 77031-505-33
  • Packager: Frozen Wheels, Llc
  • 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 5, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Use[s]

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

    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 If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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.
  • Other Information

    • Store between 15-30°C (59-86°F).
    • Avoid freezing and excessive heat above 40°C (104°F).
  • Inactive Ingredients

    demineralized water, glycerin, carbomer, aloe vera extract, triethanolamine, disodium EDTA.

  • SPL UNCLASSIFIED SECTION

    NON-STERILE SOLUTION

    Made in Mexico.

    Imported by:

    Frozen Wheels, LLC

    16565 NW 15th Ave.

    Miami, FL 33169

    Distributed by:

    Distribu LLC

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    CLEANSE PURE 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77031-505
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77031-505-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    2NDC:77031-505-014000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/18/2020
    Labeler - Frozen Wheels, Llc (069055731)
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