Label: W.R.LULUS RINSE-FREE HAND SANITIZER- ethanol solution

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    77335-001-01, 77335-001-02, 77335-001-03, 77335-001-04, view more
    77335-001-05, 77335-001-06, 77335-001-07, 77335-001-08, 77335-001-09, 77335-001-10, 77335-001-11, 77335-001-12, 77335-001-13, 77335-001-14, 77335-001-15, 77335-001-16, 77335-001-17, 77335-001-18, 77335-001-19, 77335-001-20, 77335-001-21, 77335-001-22, 77335-001-23, 77335-001-24, 77335-001-25, 77335-001-26, 77335-001-27, 77335-001-28, 77335-001-29, 77335-001-30, 77335-001-31, 77335-001-32, 77335-001-33, 77335-001-34, 77335-001-35, 77335-001-36, 77335-001-37, 77335-001-38, 77335-001-39, 77335-001-40, 77335-001-41, 77335-001-42, 77335-001-43, 77335-001-44, 77335-001-45, 77335-001-46, 77335-001-47, 77335-001-48, 77335-001-49, 77335-001-50, 77335-001-51, 77335-001-52, 77335-001-53, 77335-001-54, 77335-001-55, 77335-001-56, 77335-001-57, 77335-001-58, 77335-001-59, 77335-001-60, 77335-001-61, 77335-001-62, 77335-001-63, 77335-001-64, 77335-001-65, 77335-001-66
  • Packager: Lulus import and export co., ltd
  • 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 May 25, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredient

    Ethanol (Alcohol) 73.7% v/v

  • Purpose

    Antiseptic

  • Uses

    Hand sanitize to help reduce bacteria that potentially can cause disease.

    For use when soap and water are not available.

  • Warnings

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

    Do not use

    • on children less than 2 months of age
    • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59 - 86F). • Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients

    Carbomer, Sterile distilled Water, Triethanolamine, Glycerin, 1,2-Propanediol, Essential oil, Hydrogen peroxide

  • Questions or Comments

    Call +(86) 0755 83720787 Monday-Friday 9:00-5:00 PM

  • SPL UNCLASSIFIED SECTION

    ANTIBACTERIAL

    Alcohol Antispetic 73.7% Topical Solution

    Manufactured by Lulus import and expot co. ltd / Made in China

  • Packaging

    lulus1

  • INGREDIENTS AND APPEARANCE
    W.R.LULUS RINSE-FREE HAND SANITIZER 
    ethanol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77335-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73.7 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77335-001-010.05 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    2NDC:77335-001-020.1 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    3NDC:77335-001-030.25 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    4NDC:77335-001-040.45 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    5NDC:77335-001-05200 L in 1 DRUM; Type 0: Not a Combination Product05/12/2020
    6NDC:77335-001-061000 L in 1 CONTAINER; Type 0: Not a Combination Product05/12/2020
    7NDC:77335-001-070.02 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    8NDC:77335-001-080.025 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    9NDC:77335-001-090.03 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    10NDC:77335-001-100.04 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    11NDC:77335-001-110.059 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    12NDC:77335-001-120.06 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    13NDC:77335-001-130.073 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    14NDC:77335-001-140.08 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    15NDC:77335-001-150.106 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    16NDC:77335-001-160.118 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    17NDC:77335-001-170.12 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    18NDC:77335-001-180.15 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    19NDC:77335-001-190.2 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    20NDC:77335-001-200.207 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    21NDC:77335-001-210.22 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    22NDC:77335-001-220.221 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    23NDC:77335-001-230.237 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    24NDC:77335-001-240.296 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    25NDC:77335-001-250.3 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    26NDC:77335-001-260.35 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    27NDC:77335-001-270.355 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    28NDC:77335-001-280.4 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    29NDC:77335-001-290.444 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    30NDC:77335-001-300.473 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    31NDC:77335-001-310.5 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    32NDC:77335-001-320.532 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    33NDC:77335-001-330.55 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    34NDC:77335-001-340.8 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    35NDC:77335-001-350.999 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    36NDC:77335-001-361 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    37NDC:77335-001-371.479 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    38NDC:77335-001-382 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    39NDC:77335-001-392.5 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    40NDC:77335-001-402.957 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    41NDC:77335-001-413 L in 1 BOTTLE; Type 1: Convenience Kit of Co-Package05/12/2020
    42NDC:77335-001-423.785 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    43NDC:77335-001-434 L in 1 CAN; Type 0: Not a Combination Product05/12/2020
    44NDC:77335-001-445 L in 1 CAN; Type 0: Not a Combination Product05/12/2020
    45NDC:77335-001-457.571 L in 1 CAN; Type 0: Not a Combination Product05/12/2020
    46NDC:77335-001-4624.984 L in 1 DRUM; Type 0: Not a Combination Product05/12/2020
    47NDC:77335-001-4725 L in 1 DRUM; Type 0: Not a Combination Product05/12/2020
    48NDC:77335-001-4849.967 L in 1 DRUM; Type 0: Not a Combination Product05/12/2020
    49NDC:77335-001-4950 L in 1 DRUM; Type 0: Not a Combination Product05/12/2020
    50NDC:77335-001-500.03 L in 1 BAG; Type 0: Not a Combination Product05/12/2020
    51NDC:77335-001-510.05 L in 1 BAG; Type 0: Not a Combination Product05/12/2020
    52NDC:77335-001-520.1 L in 1 BAG; Type 0: Not a Combination Product05/12/2020
    53NDC:77335-001-530.2 L in 1 BAG; Type 0: Not a Combination Product05/12/2020
    54NDC:77335-001-540.25 L in 1 BAG; Type 0: Not a Combination Product05/12/2020
    55NDC:77335-001-550.5 L in 1 BAG; Type 0: Not a Combination Product05/12/2020
    56NDC:77335-001-560.8 L in 1 BAG; Type 0: Not a Combination Product05/12/2020
    57NDC:77335-001-571 L in 1 BAG; Type 0: Not a Combination Product05/12/2020
    58NDC:77335-001-582 L in 1 BAG; Type 0: Not a Combination Product05/12/2020
    59NDC:77335-001-590.03 L in 1 TUBE; Type 0: Not a Combination Product05/12/2020
    60NDC:77335-001-600.05 L in 1 TUBE; Type 0: Not a Combination Product05/12/2020
    61NDC:77335-001-610.06 L in 1 TUBE; Type 0: Not a Combination Product05/12/2020
    62NDC:77335-001-620.08 L in 1 TUBE; Type 0: Not a Combination Product05/12/2020
    63NDC:77335-001-630.1 L in 1 TUBE; Type 0: Not a Combination Product05/12/2020
    64NDC:77335-001-640.15 L in 1 TUBE; Type 0: Not a Combination Product05/12/2020
    65NDC:77335-001-650.2 L in 1 TUBE; Type 0: Not a Combination Product05/12/2020
    66NDC:77335-001-660.25 L in 1 TUBE; Type 0: Not a Combination Product05/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/12/2020
    Labeler - Lulus import and export co., ltd (418951770)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lulus import and export co., ltd418951770manufacture(77335-001)