Label: HAND SANITIZER gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     74658-001-01, 74658-001-02, 74658-001-03, 74658-001-04, view more
    74658-001-05, 74658-001-06, 74658-001-07, 74658-001-08, 74658-001-09, 74658-001-10, 74658-001-11, 74658-001-12, 74658-001-13, 74658-001-14, 74658-001-15, 74658-001-16, 74658-001-17, 74658-001-18, 74658-001-19, 74658-001-20
  • Packager: GUANGZHOU XUELEI COSMETIC CO.,LTD.
  • 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 November 4, 2021

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  • ACTIVE INGREDIENTS:

    ETHYL ALCOHOL 75%

  • PURPOSE

    ANTISEPTIC

  • USES

    HELPS REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

  • WARNINGS

    FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN. STOP USE AND SEEK MEDICAL ADVICE IF IRRITATION OR REDNESS DEVELOPS, OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • KEEP OUT OF REACH OF CHILDREN.

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    DISPENSE ONE PUMP OF SANITIZER ON TO HANDS AND RUB TOGETHER UNTIL DRY. USE AS NEEDED. FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION. NOT RECOMMENDED FOR INFANTS.

  • OTHER INFO

    STORE BELOW 110 (DEGREES FAHRENHEIT). MAY CAUSE DISCOLORATION TO CERTAIN FABRICS AND SURFACES.

  • INACTIVE INGREDIENTS

    WATER (AQUA), CARBOMER, TRIETHANOLAMINE.

  • Package Label

    HAND SANITIZER (60ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    60ml e (2.0 fl.oz.)

    NDC: 74658-001-01 60ml bottle label

  • Package Label

    HAND SANITIZER (60ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    60ml e (2.0 fl.oz.)

    NDC: 74658-001-02 60ml Tube Label

  • Package Label

    HAND SANITIZER (70ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    70ml e (2.36 fl.oz.)

    NDC: 74658-001-03 70ml label

  • Package Label

    100ml e (3.4 fl.oz.)

    NDC: 74658-001-04

    100ml label

  • Package Label

    HAND SANITIZER (120ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    120ml e (4.0 fl.oz.)

    NDC: 74658-001-05 120ml label

  • Package Label

    236ml e (8 fl.oz.)

    NDC: 74658-001-06

    236ml label

  • Package Label

    HAND SANITIZER (250ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    250ml e (8.5 fl.oz.)

    NDC: 74658-001-07 250ml label

  • Package Label

    HAND SANITIZER (260ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    260ml e (8.8 fl.oz.)

    NDC: 74658-001-08 260ml label

  • Package Label

    HAND SANITIZER (290ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    290ml e (9.8 fl.oz.)

    NDC: 74658-001-09 290ml label

  • Package Label

    HAND SANITIZER (300ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    300ml e (10.2 fl.oz.)

    NDC: 74658-001-10 300ml label

  • Package Label

    500ml e (17 fl.oz.)

    NDC: 74658-001-11

    500ml label

  • Package Label

    HAND SANITIZER (950ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    950ml e (32.3 fl.oz.)

    NDC: 74658-001-12 950ml label

  • Package Label

    HAND SANITIZER (1000ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    1000ml e (34 fl.oz.)

    NDC: 74658-001-13 1000ml label

  • Package Label

    HAND SANITIZER (2000ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    2000ml e (68 fl.oz.)

    NDC: 74658-001-14 2000ml label

  • Package Label

    HAND SANITIZER (30ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    30ml e (1.0 fl.oz.)

    NDC: 74658-001-15 30ml label

  • Package Label

    HAND SANITIZER (40ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    40ml e (1.35 fl.oz.)

    NDC: 74658-001-16 40ml label

  • Package Label

    HAND SANITIZER (50ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    50ml e (1.7 fl.oz.)

    NDC: 74658-001-17 50ml label

  • Package Label

    HAND SANITIZER (3785ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    3785ml e (128.68 fl.oz.)

    NDC: 74658-001-18 3785ml label

  • Package Label

    HAND SANITIZER (5000ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    5000ml e (170 fl.oz.)

    NDC: 74658-001-19 5000ml label

  • Package Label

    HAND SANITIZER (236ml)

    SCENT FREE

    SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

    KEEPS YOUR HANDS CLEAN & HYDRATED

    236ml e (8 fl.oz.) 236ml pump label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74658-001
    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
    TROLAMINE (UNII: 9O3K93S3TK) 0.22 g  in 100 mL
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) 0.4 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 22.19 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74658-001-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    2NDC:74658-001-0370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    3NDC:74658-001-04100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    4NDC:74658-001-05120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    5NDC:74658-001-06236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    6NDC:74658-001-07250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    7NDC:74658-001-08260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    8NDC:74658-001-09290 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    9NDC:74658-001-10300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    10NDC:74658-001-11500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    11NDC:74658-001-12950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    12NDC:74658-001-131000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    13NDC:74658-001-142000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    14NDC:74658-001-0260 mL in 1 TUBE; Type 0: Not a Combination Product03/18/2020
    15NDC:74658-001-1530 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    16NDC:74658-001-1750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    17NDC:74658-001-1640 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    18NDC:74658-001-183785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    19NDC:74658-001-195000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
    20NDC:74658-001-20236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/18/2020
    Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
    Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU XUELEI COSMETIC CO.,LTD.526885026manufacture(74658-001) , pack(74658-001) , label(74658-001)
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