Label: HAND SANITIZER- alcohol 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 18, 2021

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  • Active Ingredient(s)

    Alcohol denat 62%

  • Purpose

    Antiseptic

  • Use

    for hadwashing to decrease bacteria on the skin

  • Warnings

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

  • Do not use

    dose not contain grain alcohol,do not drink,if taken internally will produce serious gastric distubances.

  • WHEN USING

    When using this product

    avoid contact with eyes,if contact occurs,flush eyes with water

    avoid contact with broken skin

  • STOP USE

    Stop use and ask a doctor if condition worsens

    redness or irrtation develops

    contidion persists fro more than 3 days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    in case of accidental ingestion ,seek professinal assistance or contact a Poison Control Center immediately.

  • Directions

    • rub dime sized amount between hands until dry.
    • supervise children in the use of this product.
    • in the case of eye contact ,rinse eyes thoroughly with water.
    • wet hands with product and allow to dry without wiping.
  • Other information

    Store at 68° to 77F(20° to 25°c).
    Do not store above 105°.
    May discolor some fabrics.
    Not recommended for infants.
    Harmful to wood finishes and
    plastics.

  • Inactive ingredients

    Water(Aqua), Glycerin, Carbome,Triethanolamine, Fragrance(Parfum),Lactose,
    Cellulose, Hydroxypropyl Methylcellulose,Jojoba Estes, locopheryl Acetate, Ascorbyl,Palmitate, Ultramarines(CI 77007),
    D&C Red NO.33(CI 17200),FD&C YVellow No.5(Cl 19140).

  • Package Label - Principal Display Panel

    30 mL WMCA20S021-1 NDC: 51706-964-01

    1

    30 mL WMCA20S039 NDC: 51706-964-02

    2

    30 mL WST21A066 NDC: 51706-964-03

    3

    30 mL WST21A070R NDC: 51706-964-04

    4

    30 mL WST21A065B NDC: 51706-964-05

    5

    30 mL WST21A065P NDC: 51706-964-06

    6

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-964
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-964-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
    2NDC:51706-964-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
    3NDC:51706-964-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
    4NDC:51706-964-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
    5NDC:51706-964-0530 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
    6NDC:51706-964-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-964)
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