SCHOOL HEALTH HAND SANITIZER- alcohol gel 
Commercial Beverage Concepts, LLC

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. Isopropyl Alcohol (75%, 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)

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

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 ingest or inhale.

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. Condition persists for more than 72 hours.

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, Isopropyl Myristate, Polyethylene Glycol/Acrylates Copolymer, Tocopheryl Acetate, Water

Package Label - Principal Display Panel

237 mL NDC: 75594-090-01 School Health 8oz Label

473 mL NDC: 75594-090-02 School Health 16oz Label

946 mL NDC: 75594-090-03 School Health 32oz Label

3.785 L NDC: 75594-090-04 School Health 1 gal label

SCHOOL HEALTH HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75594-090(NDC:74221-003)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75594-090-020.437 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
2NDC:75594-090-030.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
3NDC:75594-090-043.785 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
4NDC:75594-090-010.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/28/2020
Labeler - Commercial Beverage Concepts, LLC (080925174)
Establishment
NameAddressID/FEIBusiness Operations
Commercial Beverage Concepts, LLC080925174pack(75594-090) , label(75594-090) , relabel(75594-090) , repack(75594-090)

Revised: 7/2020
Document Id: ab76590b-0606-17e2-e053-2995a90a75e9
Set id: ab76cfdc-3f66-d5aa-e053-2a95a90a79a8
Version: 1
Effective Time: 20200727
 
Commercial Beverage Concepts, LLC