Label: HAND CLEANER 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 April 2, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Ethyl alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    to decrease bacteria on the skin that could cause disease

    recommended for repeated use

  • Warnings

    For external use only: hands

    Flammable, keep away from fire or 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

    irritation and redness develop

    condition persists for more than 72 hours

  • Directions

    wet hands thoroughly with product and allow to 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, Sodium Hyaluronate, Glycerin, 1,2-Hexanediol, Triethanolamine, Carbomer, Panthenol, Propylene Glycol, Glycyrrhiza Glabra (licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Schisandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Camellia Sinensis Leaf Extract, Propolis Wax, Butylene Glycol, Asiaticoside, Citrus Paradisi (Grapefruit) Fruit Extract, Pinus Sylvestris Leaf Extract, Caprylyl Glycol

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Package Label

    NDC 74429 311 Label

  • INGREDIENTS AND APPEARANCE
    HAND CLEANER HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74429-311
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.035 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 35.2245 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.45 mL  in 100 mL
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.005 mL  in 100 mL
    1,2-HEXANEDIOL (UNII: TR046Y3K1G) 0.03 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.2 mL  in 100 mL
    COPTIS JAPONICA ROOT (UNII: JH0SWT16D1) 0.005 mL  in 100 mL
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) 0.0025 mL  in 100 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.055 mL  in 100 mL
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.0025 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.35 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.35 mL  in 100 mL
    PANTHENOL (UNII: WV9CM0O67Z) 0.3 mL  in 100 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) 0.05 mL  in 100 mL
    SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C) 0.005 mL  in 100 mL
    GINGER (UNII: C5529G5JPQ) 0.005 mL  in 100 mL
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.005 mL  in 100 mL
    ASIATICOSIDE (UNII: PKO39VY215) 0.0005 mL  in 100 mL
    GRAPEFRUIT (UNII: O82C39RR8C) 0.435 mL  in 100 mL
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) 0.49 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74429-311-0127 mL in 1 POUCH; Type 0: Not a Combination Product04/10/2020
    2NDC:74429-311-0250 mL in 1 TUBE; Type 0: Not a Combination Product04/10/2020
    3NDC:74429-311-03100 mL in 1 TUBE; Type 0: Not a Combination Product04/10/2020
    4NDC:74429-311-04300 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/10/2020
    5NDC:74429-311-05300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/10/2020
    6NDC:74429-311-06500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2020
    Labeler - i9biz, Inc (064260178)
    Registrant - BL Cosmetic Co., Ltd (695735124)
    Establishment
    NameAddressID/FEIBusiness Operations
    BL Cosmetic Co., Ltd695735124manufacture(74429-311)