Label: 75% HAND SANITIZER- alcohol gel

  • NDC Code(s): 75532-001-01, 75532-001-02, 75532-001-03, 75532-001-04, view more
    75532-001-05
  • Packager: Shandong Retouch Wash And Sterilize Technology Co.,ltd.
  • 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 February 10, 2023

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    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 or if allergy to alcohol
  • 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.

  • Directions

    Take 3mL of the product to moisten your hands and rub for 1 min until the liquid covers your hands, wait until dry, and no need to wash with water.

  • Other information

    Store in a cool, dry place (below 86F). Keep sealed.

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Inactive ingredients

    Carbomer, Triethanolamine, Emollients, Essence and purified water

  • Package Label - Principal Display Panel

    60 mL NDC:75532-001-01

    PDP

    250 mL NDC:75532-001-02

    PDP

    500 mL NDC:75532-001-03

    PDP

    1000 mL NDC:75532-001-04

    PDP4000 mL NDC:75532-001-05

    PDP

  • INGREDIENTS AND APPEARANCE
    75% HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75532-001
    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
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75532-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    2NDC:75532-001-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    3NDC:75532-001-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    4NDC:75532-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    5NDC:75532-001-054000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/21/2020
    Labeler - Shandong Retouch Wash And Sterilize Technology Co.,ltd. (529300365)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Retouch Wash And Sterilize Technology Co.,ltd.529300365manufacture(75532-001)
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