Label: 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 January 16, 2020

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  • Active Ingredient

    Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    ■ For hand washing to decrease bacteria on the skin and ■ Recommended for daily and repeated use.

  • Warnings

    For external use only. Flammable. Keep away from fire & flame

  • When using this product

    ■ do not use in the eyes. In case of contact, rinse eyes thoroughly with water

  • Stop use and ask a doctor if

    ■ irritation and redness develop and persist for more than 72 hours

  • Keep out of reach of children

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

  • Directions

    ■ Wet hands throughhly with product, briskly rub hands together until they are dry. ■ Supervise children in the use of this product.

  • Other information

    ■ Store below 105ºF

    ■ May discolor some fabrics

  • Other information

    ■ Store at 20º-25º C (68º to 72º F) ■ may discolor certain fabrics

  • Inactive Ingredients

    distilled water, carbopol, triethanolamine, glycerin

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50058-100
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50058-100-08250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/03/2020
    Labeler - Roqueplast, S.A. de C.V. (814567731)
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