Label: FRESHORIZE- 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 May 16, 2020

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  • Active lngredient  

    Ethyl Alcohol 70 %v/v

  • Purpose

    Hand wipes

  • Uses

    For handwashing to decrease bacteria on the skin - recommended for repeated use

  • Warnings  


    For external use only.

    Flammable. Keep away from fire or flame.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persist 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

    Tear open packet, unfold and use wipe on surface or hands.

    Allow to air dry without washing

    Supervise children under 6 years in the use of this product

  • Inactives 

    Water (Aqua)

  • Keep out of reach of children.

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

  • Other information

    • Store at 20°C to 25°C (68° to 77°F)
    • May discolor certain fabrics.
  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    FRESHORIZE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52305-500
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52305-500-101 in 1 PACKET05/16/2020
    11.4 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:52305-500-2010 in 1 PACKET05/16/2020
    214 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:52305-500-3025 in 1 PACKET05/16/2020
    335 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:52305-500-4050 in 1 PACKET05/16/2020
    470 mL in 1 PACKET; Type 0: Not a Combination Product
    5NDC:52305-500-50100 in 1 PACKET05/16/2020
    5140 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/16/2020
    Labeler - FRESHORIZE, LTD. (424168503)
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