FOAMING HAND SANITIZER V- alcohol solution 
FOAMING HAND SANITIZER MM- alcohol solution 
HAND SANITIZER- alcohol solution 
ECOFREAKS NON-ALCOHOL SANITIZER- benzalkonium chloride solution 
ECOFREAKS HAND SANITIZER- alcohol solution 
The Millennium Mat Company

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) (80%, 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. Sterile distilled water or boiled cold water.

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 80% 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 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

  • 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

75555-001-01: 2mL Hand Sanitizer Packet 75555-001-01

75555-001-02: 125ct Box of 2mL Hand Sanitizer Packets 75555-001-02

75555-001-03: 100mL Hand Sanitizer Pouch 75555-001-03

75555-001-08: 8oz Hand Sanitizer Bottle 75555-001-08

75555-001-12: 375mL Hand Sanitizer Bottle 75555-001-12

75555-001-16: 16oz Hand Sanitizer Bottle 75555-001-16

75555-001-32: 32oz Hand Sanitizer Bottle 75555-001-32

75555-001-98: 55gal Drum Hand Sanitizer 75555-001-98

75555-001-99: 1gal Hand Sanitizer Bottle 75555-001-99

75555-002-17: 500mL Hand Sanitizer Bag 75555-002-17

75555-003-17: 500mL Foaming Hand Sanitizer Bag 75555-003-17

75555-010-16: 16oz Bottle Unscented Hand Sanitizer Gel 75555-010-16

75555-011-16: 16oz Bottle Orange Scent Hand Sanitizer Gel 75555-011-16

75555-110-16: 16oz Bottle Non-Alcohol Hand Sanitizer 75555-110-16

75555-110-90: 10L Cannister 1000 Wipes BZK 75555-110-90

FOAMING HAND SANITIZER V 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75555-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WATER (UNII: 059QF0KO0R)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEADOWFOAMAMIDOPROPYL BETAINE (UNII: HNV0L650LG)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75555-002-17500 mL in 1 BAG; Type 0: Not a Combination Product06/15/202008/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/202008/31/2020
FOAMING HAND SANITIZER MM 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75555-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75555-003-17500 mL in 1 BAG; Type 0: Not a Combination Product06/09/202008/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/202008/31/2020
HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75555-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75555-001-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/202008/31/2020
2NDC:75555-001-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/202008/31/2020
3NDC:75555-001-993785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/202008/31/2020
4NDC:75555-001-012 mL in 1 PACKET; Type 0: Not a Combination Product03/30/202008/31/2020
5NDC:75555-001-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202008/31/2020
6NDC:75555-001-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202008/31/2020
7NDC:75555-001-12375 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202008/31/2020
8NDC:75555-001-17500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202008/31/2020
9NDC:75555-001-02125 in 1 CARTON06/09/202008/31/2020
92 mL in 1 PACKET; Type 0: Not a Combination Product
10NDC:75555-001-98208198 mL in 1 DRUM; Type 0: Not a Combination Product07/06/202008/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202008/31/2020
ECOFREAKS NON-ALCOHOL SANITIZER 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75555-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75555-110-16473 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/202008/31/2020
2NDC:75555-110-902500 g in 1 CANISTER; Type 0: Not a Combination Product08/01/202008/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/202008/31/2020
ECOFREAKS HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75555-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75555-010-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/202008/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/202008/31/2020
ECOFREAKS HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75555-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75555-011-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/202008/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/202008/31/2020
Labeler - The Millennium Mat Company (068341010)

Revised: 1/2022
Document Id: bc06f380-bc6f-14ed-e053-2a95a90a7fbc
Set id: a3e76296-bf59-9245-e053-2995a90ae251
Version: 14
Effective Time: 20220101
 
The Millennium Mat Company