Label: RRUB RINSE FREE HAND WASH-ALCOHOL VERSION- alcohol liquid
RRUB RINSE FREE HAND WASH-NON ALCOHOL VERSION- benzalkonium chloride liquid
RRUB BODY SANITIZING- benzalkonium chloride liquid

  • 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 December 15, 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) (75%, 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. MET® Microbe Encapsulation Technology ingredients.
    4. Sterile distilled water or boiled cold water.

    The MET® Microbe Encapsulation Technology ingredients help to physically remove the dead bacteria killed by actives ingredients. Thus the effectiveness is enhanced than sanitizing only.

  • Active Ingredient(s)

    alcohol version: Alcohol 75% v/v. Purpose: Antiseptic

    non-alcohol version: Benzalkonium chloride, cetyl Pyridinium chloride. 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, purified water USP, MET® Microbe Encapsulation Technology ingredients.

  • Package Label - Principal Display Panel

    sanitizing body spray bottlerrub Rinse-free Hand Wash Alcohol version NDC: 78974-0001 rrub hand sanitizer alcohol

    rrub Rinse-free Hand Wash Non-alcohol version NDC: 78974-0002 hand sanitizer-alcohol free

    Sanitizing Body Spray

  • INGREDIENTS AND APPEARANCE
    RRUB RINSE FREE HAND WASH-ALCOHOL VERSION 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78974-0001
    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
    ALPHA CELLULOSE (UNII: I355QGZ19A) 0.5 mL  in 100 mL
    HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) 0.5 mL  in 100 mL
    CITRIC ACID, 1-STEARYL ESTER (UNII: E945AJ51FA) 0.2 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78974-0001-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/15/2020
    2NDC:78974-0001-2400 mL in 1 BAG; Type 0: Not a Combination Product07/15/2020
    3NDC:78974-0001-360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    RRUB RINSE FREE HAND WASH-NON ALCOHOL VERSION 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78974-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 100 mL
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    ALPHA CELLULOSE (UNII: I355QGZ19A) 0.1 mL  in 100 mL
    HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) 0.1 mL  in 100 mL
    CITRIC ACID, 1-STEARYL ESTER (UNII: E945AJ51FA) 0.2 mL  in 100 mL
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) 0.1 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78974-0002-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/15/2020
    2NDC:78974-0002-2400 mL in 1 BAG; Type 0: Not a Combination Product07/15/2020
    3NDC:78974-0002-360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    RRUB BODY SANITIZING 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78974-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 100 mL
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    ALPHA CELLULOSE (UNII: I355QGZ19A) 0.1 mL  in 100 mL
    HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) 0.1 mL  in 100 mL
    CITRIC ACID, 1-STEARYL ESTER (UNII: E945AJ51FA) 0.2 mL  in 100 mL
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) 0.1 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78974-0003-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
    2NDC:78974-0003-160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/20/2020
    Labeler - CHAMPS INDUSTRIAL PTE LTD (595851023)
    Registrant - CHAMPS INDUSTRIAL PTE LTD (595851023)
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