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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Gel Hand Sanitizer 70%, 946mL

DRUG FACTS

ACTIVE INGREDIENT [S]

ALCOHOL 70% v/v

PURPOSE

ANTISEPTIC

USE[S]

Health care personnel hand rub to help reduce baceria that potentionally can cause disease.

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.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

PEG-6 & AMP, Glycerin, Acrylates / Vinyl Isodecanoate Crosspolymer, Tocopheryl Acetate, Isopropyl Myristate, Fragrance (Parfum).

Package Labeling:

full label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75594-170
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
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
GLYCERIN (UNII: PDC6A3C0OX)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75594-170-12946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - Commercial Beverage Concepts, LLC (080925174)

Revised: 6/2020
Document Id: a7b9b1c5-2857-541c-e053-2995a90a1cc9
Set id: a7b9a176-78ac-585b-e053-2995a90a1d91
Version: 1
Effective Time: 20200610
 
Commercial Beverage Concepts, LLC