Label: SERVCLEAN GEL HAND SANITIZER- alcohol 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 September 1, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (71%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Distilled water.
    5. 2,4-D diethylethanolamine
    6. acrylates crosspolymer

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 71% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer 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 heat or flame

  • Do not use

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

    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.

  • STOP USE

    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

    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

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    1250 ml label1250 mL NDC: 64646-380-04

    500ml label500ml NDC:64646-380-12

    2000 mL label

    2L NDC:64646-380-02

    3.78L label3.78 NDC:64646-380-03

    18.9 L label18.9 L NDC:64646-380-20

    55L label55L NDC:64646-380-21

    208 L label208L NDC:64646-380-22

    1000L label1000L NDC:64646-380-23

    ES43 1250 ml1250 mL NDC: 64646-043-04

    ES43 500 ml label500 mL NDC:64646-043-12

    ES43 2L label2L NDC:64646-043-02

    ES43 3.78 L label3.78L NDC:64646-043-03

    ES43 18.9L label18.9 L NDC: 64646-043-20

    ES43 55 L label55 L NDC: 64646-043-21

    ES43 208L label208L NDC: 64646-043-22

    ES43 1000 L Label1000L NDC: 64646-043-23

  • INGREDIENTS AND APPEARANCE
    SERVCLEAN GEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64646-380
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) 0.3 mL  in 100 mL
    2,4-D DIETHYLETHANOLAMINE (UNII: S070272I1T) 0.21 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.12 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64646-380-041250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/10/2021
    2NDC:64646-380-12500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/10/2021
    3NDC:64646-380-022000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/10/2021
    4NDC:64646-380-033780 mL in 1 BOTTLE; Type 0: Not a Combination Product09/10/2021
    5NDC:64646-380-2018900 mL in 1 PAIL; Type 0: Not a Combination Product09/10/2021
    6NDC:64646-380-2155000 mL in 1 DRUM; Type 0: Not a Combination Product09/10/2021
    7NDC:64646-380-22208000 mL in 1 DRUM; Type 0: Not a Combination Product09/10/2021
    8NDC:64646-380-231000000 mL in 1 DRUM; Type 0: Not a Combination Product09/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/10/2021
    Labeler - Charlotte Products Ltd. (248293359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Charlotte Products Ltd.248293359manufacture(64646-380)
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