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 November 9, 2021

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  • Active Ingredient

    Alcohol（75% v//v）

  • Purpose

    Antiseptic

  • Uses

    help decrease bacteria on the hands

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame. Do not store in car.

    Avoid contact with eyes, in case of contact, rinse eyes thoroughly with water immediately

    Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center right away.

    If irritation develops, discontinue use and consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.

  • Other Information

    May discolor fabrics or surfaces. Store below 95 °F (35 ° C).

  • Inactive ingredients

    Carbomer, Denatonium Benzoate, Purified Water USP, Tert-butyl Alcohol, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    50ml NDC: 74658-010-01

    50ml label

    60ml NDC: 74658-010-02

    60ml label

    236ml NDC: 74658-010-03

    236ml label

    250ml NDC: 74658-010-04

    250ml label

    260ml NDC: 74658-010-05

    260ml label

    300ml NDC: 74658-010-06

    300ml label

    500ml NDC: 74658-010-07

    500ml label

    1000ml NDC: 74658-010-08

    1000ml label

    5000ml NDC: 74658-010-09

    5000ml label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74658-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 22.1937 g  in 100 mL
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.0809 g  in 100 mL
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) 0.4 g  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.22 g  in 100 mL
    DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 0.0004 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74658-010-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
    2NDC:74658-010-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
    3NDC:74658-010-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
    4NDC:74658-010-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
    5NDC:74658-010-05260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
    6NDC:74658-010-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
    7NDC:74658-010-07500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/02/2020
    8NDC:74658-010-081000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/02/2020
    9NDC:74658-010-095000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/02/2020
    Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
    Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU XUELEI COSMETIC CO.,LTD.526885026manufacture(74658-010) , pack(74658-010) , label(74658-010)
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