Label: INSTANT HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 April 27, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 62% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    To reduce bacteria on the skin that could cause disease

    Recommended for repeated use

    Use anywhere without water

  • Warnings

    For external use only -hands

    Flammable. Keep away from heat and flame

  • WHEN USING

    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

    Discontinue if skin becomes irritated and ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingest, seek professional assistance or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and rub until dry without wiping
    • For children under 6, use only under adult supervision
    • Not recommended for infants
  • Other information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Water, propylene glycol, glycerin, carbomer, triethanolamine, fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75236-001
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75236-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    2NDC:75236-001-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    3NDC:75236-001-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    4NDC:75236-001-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    5NDC:75236-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/27/2020
    Labeler - PUJIANG SHIJIALI COSMETICS CO., LTD. (529748603)
    Establishment
    NameAddressID/FEIBusiness Operations
    PUJIANG SHIJIALI COSMETICS CO., LTD.529748603manufacture(75236-001)
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