SERVCLEAN LIQUID HAND SANITIZER- alcohol liquid 
Charlotte Products 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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Liquid Hand Sanitizer

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

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, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

Liquid Hand Sanitizer 500 ML NDC 64646-329-12

Liquid Hand Sanitizer 500 ML NDC 64646-329-12


Liquid Hand Sanitizer 3.78 Litres NDC 64646-329-04

Liquid Hand Sanitizer 3.78 Litres NDC 64646-329-04

Liquid Hand Sanitizer 100 ML NDC 64646-329-70

Liquid Hand Sanitizer 100 ML NDC 64646-329-70

Liquid Hand Sanitizer 100 ML NDC 64646-329-96

Liquid Hand Sanitizer 100 ML NDC 64646-329-96

Liquid Hand Sanitizer 60ml NDC 64646-329-60

Liquid Hand Sanitizer 60ml NDC 64646-329-60

Liquid Hand Sanitizer 1890 ml NDC 64646-329-19

Liquid Hand Sanitizer 1890 ml NDC 64646-329-19

Liquid Hand Sanitizer 750 ml NDC 64646-329-75

Liquid Hand Sanitizer 750 ml NDC 64646-329-75

Liquid Hand Sanitizer 2 Litres NDC 64646-329-02

Liquid Hand Sanitizer 2 Litres NDC 64646-329-02

Liquid Hand Sanitizer 225 ML NDC 64646-329-25

Liquid Hand Sanitizer 225 ML NDC 64646-329-25

Liquid Hand Sanitizer 3.6 Litres NDC 64646-329-03

Liquid Hand Sanitizer 3.6 Litres NDC 64646-329-03

Liquid Hand Sanitizer 700 ML NDC 64646-329-07

Liquid Hand Sanitizer 700 ML NDC 64646-329-07

Liquid Hand Sanitizer Pail 64646-329-20

Liquid Hand Sanitizer Pail 64646-329-20

Liquid Hand Sanitizer Drum 64646-329-21

Liquid Hand Sanitizer Drum 64646-329-21

Liquid Hand Sanitizer IBC 64646-329-22

Liquid Hand Sanitizer IBC 64646-329-22

SERVCLEAN LIQUID HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64646-329
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64646-329-70100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:64646-329-12500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
3NDC:64646-329-043780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:64646-329-96100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
5NDC:64646-329-6060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
6NDC:64646-329-191890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
7NDC:64646-329-75750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
8NDC:64646-329-022000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
9NDC:64646-329-25225 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
10NDC:64646-329-033600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
11NDC:64646-329-07700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
12NDC:64646-329-2018900 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
13NDC:64646-329-221000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
14NDC:64646-329-21208000 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Charlotte Products Ltd (248293359)
Registrant - Charlotte Products Ltd (248293359)
Establishment
NameAddressID/FEIBusiness Operations
Charlotte Products Ltd248293359manufacture(64646-329)

Revised: 9/2020
Document Id: af022842-11b3-5dce-e053-2995a90a584c
Set id: a6ceace2-ed87-c5b1-e053-2a95a90a164b
Version: 2
Effective Time: 20200910
 
Charlotte Products Ltd