HAND SANITIZER- alcohol liquid 
CLASSIC WINE VINEGAR COMPANY INC

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. Purified 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)

DENATURED ETHANOL AND GLYCERIN

Purpose

THIS PRODUCT IS AN ANTIMICROBIAL HAND SANITIZER THAT MEETS THE REQUIREMENTS OF THE USDA TO BE USED AS AN E3 ANTIMICROBIAL HAND SANITIZER.

SANITIZES HANDS TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

FLAMMABLE LIQUID AND VAPOR. KEEP AWAY FROM FLAME.

CAUSES SERIOUS EYE IRRITATION. IF IT GETS IN YOUR EYES RINSE WITH WATER FOR SEVERAL MINUTES. IF IRRITATION PERSISTS SEEK MEDICAL ATTENTION.

HARMFUL IF SWALLED SEEK MEDICAL ATTENTION OR CALL POISON CONTROL CENTER IMMEDIATELY.

IT IS MPORTANT TO KEEP AWAY FROM HEAT, SPARKS, OPEN FLAMES AND HOT SURFACES AS THIS PRODUCT IS HIGHLY FLAMMABLE. USE CAUTION AROUND AREAS WITH STATIC DISCHARGE. AKE SURE LID IS SEALED TIGHTLY AFTER USE.

CAUSES SERIOUS EYE IRRITATION. IF IT GETS IN YOUR EYES RINSE WITH WATER FOR SEVERAL MINUTES. IF IRRITATION PERSISTS SEEK MEDICAL ATTENTION. HARMFUL IF SWALLOWED. SEEK MEDICAL ATTENTION OR CALL POISON CONTROL CENTER IMMEDIATELY

Directions

APPLY ENOUGH OF THIS PRODUCT TO COVER THE ENTIRE SURFACE OF YOUR HANDS INCLUDING THE FINGERTIPS, CUTICLES, AND WRISTS. THOROUGHY RUB HANDS TOGETHER UNTIL COMPLETELY DRY. NO NEED TO RINSE HANDS AFTER USING THIS PRODUCT..

Inactive ingredients

glycerin, purified water USP

KEEP OUT OF REACH OF CHILDREN

Package Label - Principal Display Panel

50mL NDC: 75600-807-50

50 mL NDC 75600-807-50

3785mL NDC: 75600-807-01

3785mL NDC 75600-87-01

208197mL NDC: 75600-807-55

20817mL NDC 75600-807-55

1040988 mL NDC: 75600-807-27

1040988mL NDC 75600 807 27

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75600-807
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75600-807-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:75600-807-0415141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
3NDC:75600-807-501 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:75600-807-271040988 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
5NDC:75600-807-55208197 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
6NDC:75600-807-12125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
7NDC:75600-807-25250 mL in 1 BOTTLE, PLASTIC; 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 - CLASSIC WINE VINEGAR COMPANY INC (958561607)
Registrant - CLASSIC WINE VINEGAR COMPANY INC (958561607)
Establishment
NameAddressID/FEIBusiness Operations
CLASSIC WINE VINEGAR COMPANY INC958561607manufacture(75600-807)

Revised: 4/2020
Document Id: a3baa00a-24f1-55cf-e053-2a95a90ac1a0
Set id: a3ba9fa7-d41d-9918-e053-2995a90ac2f8
Version: 1
Effective Time: 20200420
 
CLASSIC WINE VINEGAR COMPANY INC