Label: MULTI PURPOSE STERILIZATION HAND SANITIZER- alcohol spray

  • 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 4, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: Ethyl alcohol 83.0% v/v

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water

  • PURPOSE

    Purpose: ANTISEPTIC

  • WARNINGS

    Warnings:

    For external use only-hands

    Flammable. Keep away from heat and flame.

    When using this product ■ Keep out of eyes. 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 skin irritation or rash develops.

  • 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.

  • Uses

    Uses:

    ■ Hand sanitizer to decrease bacteria on the skin that could cause disease
    ■ Disinfection of the skin at the surgical site

  • Directions

    Directions:

    ■ Spray the product on skin or other place where disinfection is required.
    ■ Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

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

  • Questions

    Questions
    http://www.glpharm.co.kr or TEL : +82-43-537-7001

  • Package Label : Multi-purpose sterilization hand sanitizer 100mL

    Image of bottle

  • Package Label : Multi-purpose sterilization hand sanitizer 300mL

    Image of bottle

  • Package Label : Multi-purpose sterilization hand sanitizer 250mL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    MULTI PURPOSE STERILIZATION HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74713-0510
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL83 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74713-0510-1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2020
    2NDC:74713-0510-2300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2020
    3NDC:74713-0510-3250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - GL Pharm. Co., Ltd. (694506955)
    Registrant - GL Pharm. Co., Ltd. (694506955)
    Establishment
    NameAddressID/FEIBusiness Operations
    GL Pharm. Co., Ltd.694506955manufacture(74713-0510)
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