Label: HAND SANITIZER 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 July 23, 2020

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  • Active ingredient

    Ethyl alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    Helps reduce bacteria that potentially can cause disease

    Helps prevent cross contamination on contact

    Recommended for repeated use

  • Warnings

    Flammable, keep away from open flame and sources of heat

    External use only

    Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

    Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

    Keep out of reach of children

  • DO NOT USE

    Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

  • WHEN USING

  • STOP USE

    Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

  • Keep out of reach of children

    Keep out of reach of children

    If swallowed, call a poison control center or get medical help right away .

  • Directions

    Wet hands thoroughly with product and rub completely covering hands

    ·Allow to dry without wiping

    ·Children under the age of 6 should use with adult supervision

    Not recommended for infants

  • Other information

    Store below 105F(41C)

    May discolor certain fabrics or surfaces.

  • Inactive ingredients

    Water, Acrylates/C10- Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance

    PEG-40 Hydrogenated Castor Oil. May man FD&C RED NO 4( 14700), D& REN0.33(C 17200), FD&C YELLOW NO 5(C 19140), FD&C BLUE NO. 1(CI 42090)

  • Package Label Principal Display Panel

    1234

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73549-008
    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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    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:73549-008-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
    2NDC:73549-008-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
    3NDC:73549-008-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
    4NDC:73549-008-041800 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/23/2020
    Labeler - Fortress Expert Co., Ltd (543358697)
    Registrant - Fortress Expert Co., Ltd (543358697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fortress Expert Co., Ltd543358697manufacture(73549-008)
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