Label: CENTROLL NAP ADVANCED HAND SANITIZER GEL- alcohol 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 July 21, 2021

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  • Active ingredient

    Alcohol 70 %

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria on the skin.

    For use when soap and water are not available.

  • Warnings

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

  • Do not use

    ■ in 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 hand together until dry.

    ■ Apply it in a well-ventilated area.

    ■ Supervise children under 6 years of age when using this product to avoid swallowing.

    ■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)

    ■ This product is intended only for hand sanitizing.

    ■ To prevent contents from drying out and contaminants from entering, close lid completely after use.

    ■ Keep product in its original container as storing the product in anything other than the original container may result in accidents or cause the integrity of the product to diminish.

    ■ Do not use over bandages, castings, etc. as irritation may occur.

  • Other information

    ■ Store between 15-30 °C (59-86 °F)

    ■ Avoid freezing and excessive heat above 40 °C (104 °F)

  • Inactive ingredients

    Water, Citric acid, Aminomethylpropanol, Urea, Carbomer homopolymer,Tocopherol acetate, Isopropyl myristate, Glycerin, Dexpanthenol, Glycyrrhiza Glabra (Licorice) Root Extract

  • PRINCIPAL DISPLAY PANEL

    Centroll NAP ADVANCED Hand Sanitizer Gel

  • INGREDIENTS AND APPEARANCE
    CENTROLL NAP ADVANCED HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82037-510
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UREA (UNII: 8W8T17847W)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82037-510-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/22/2021
    Labeler - SUNGIN PHARMA (688719819)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUNGIN PHARMA688719819manufacture(82037-510)