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 
CHAMPS INDUSTRIAL PTE LTD

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.

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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

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 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

Other information

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

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)

Revised: 12/2021
Document Id: d32bbe66-a4e1-310f-e053-2995a90ae624
Set id: a69a69f8-5081-6b7a-e053-2995a90a9606
Version: 7
Effective Time: 20211215
 
CHAMPS INDUSTRIAL PTE LTD