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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Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

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

Fragrance (parfum), Glycerin, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoete Crosspolymer, Water

Package Label - Principal Display Panel

HHCO 128oz3.78L, NDC: 75594-006-08

HHCO 2oz.059L, NDC: 75594-006-01

HHCO 4oz.12L, NDC: 75594-006-02

HHCO 12oz.354L, NDC: 75594-006-04

HHCO 8oz.237L, NDC: 75594-006-03

HHCO 16oz.477L, NDC: 75594-006-05

HHCO 32oz.946L, NDC: 75594-006-06

HHCO 64oz1.89L, NDC: 75594-006-07

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75594-006(NDC:74221-006)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75594-006-010.059 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/12/2020
2NDC:75594-006-020.12 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/12/2020
3NDC:75594-006-030.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
4NDC:75594-006-040.354 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
5NDC:75594-006-050.477 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
6NDC:75594-006-060.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
7NDC:75594-006-071.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
8NDC:75594-006-083.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/12/2020
Labeler - Commercial Beverage Concepts, LLC (080925174)
Establishment
NameAddressID/FEIBusiness Operations
Commercial Beverage Concepts, LLC080925174relabel(75594-006) , repack(75594-006) , label(75594-006) , pack(75594-006)

Revised: 8/2020
Document Id: acb1ae8f-9cc3-6309-e053-2995a90ad6a4
Set id: acb17917-fca1-6727-e053-2995a90a5968
Version: 1
Effective Time: 20200812
 
Commercial Beverage Concepts, LLC