Label: HAND SANITIZER 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 May 8, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 62% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    take about 2ml of this product and apply it directly to the skinof hand 1 mindy, no need to wash. Continuous multiple usepossible Slightly sticky and can be washed with water.

  • Warnings

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

  • Do not use

    /

  • 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 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 helper contact a Poison Control Center right away

  • 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

    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

    • Other information Avoid freezing and Store between41c(106F
  • Inactive ingredients

    glycerin, water, Carbomer, Triethanolamine

  • Package Label - Principal Display Panel

    12345

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75759-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75759-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:75759-001-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:75759-001-03200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:75759-001-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:75759-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Yiwu Pafa Trading Firm (General Partnership) (551964379)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Pafa Trading Firm (General Partnership)551964379manufacture(75759-001)
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