Label: HAND SANITIZER- alcohol liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):     77451-301-01, 77451-301-02, 77451-301-03, 77451-301-04, view more
    77451-301-05, 77451-301-06, 77451-301-07, 77451-301-08, 77451-301-09, 77451-301-10, 77451-301-11, 77451-301-12, 77451-301-13, 77451-301-14, 77451-301-15, 77451-301-16, 77451-301-17, 77451-301-18, 77451-301-19, 77451-301-20
  • Packager: Jewellery Time Limited
  • 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 July 20, 2020

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  • SPL UNCLASSIFIED SECTION

    Hand Sanitizer

  • Active Ingredient(s)

    Alcohol 70% 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
  • 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 help or 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

    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

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

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    12

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77451-301
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77451-301-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:77451-301-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:77451-301-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:77451-301-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:77451-301-05120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:77451-301-06120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:77451-301-07300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    8NDC:77451-301-08300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    9NDC:77451-301-09500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    10NDC:77451-301-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    11NDC:77451-301-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    12NDC:77451-301-121000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    13NDC:77451-301-131200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    14NDC:77451-301-141200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    15NDC:77451-301-154000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    16NDC:77451-301-164000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    17NDC:77451-301-175000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    18NDC:77451-301-185000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    19NDC:77451-301-1925000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    20NDC:77451-301-2025000 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 - Jewellery Time Limited (664342242)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jewellery Time Limited664342242manufacture(77451-301)
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