Label: HAND SANITIZER 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 August 3, 2020

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  • Active ingredient

    Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    ■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use

  • Warnings

    ■ For external use only

    ■ Flammable, keep away from open flame and sources of heat

    ■ Does not contain grain alcohol; do not drink. If taken internally will produce gastric distrubances.

  • When using this product

    ■ Avoid the eyes and mucoous membranes

    ■ In the case of eyes or mucous membranes contacr, rinse area thoroughly with water

  • Stop use and ask a doctor if

    ■ Condition worsens

    ■ Redness or irritation develops

    ■ Condition persists for more than 3 days

  • Keep out of reach of children

    ■ If swallowed, contact a doctor or 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.

  • Other information

    ■ Store below 105ºF

    ■ May discolor some fabrics.

  • Inactive ingredients

    Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, PEG-40 Hydrogenated Castor Oil, FD&C BLUE NO.1, FD&C YELLOW NO.5

  • Questions?

    ■ 1-800-278-9218

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73549-009
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73549-009-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/30/2020
    Labeler - Fortress Expert Co., Ltd (543358697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fortress Expert Co., Ltd543358697manufacture(73549-009)
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