HAND SANITIZER- isopropyl alcohol gel 
Maryland Correctional Enterprises

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 Ingredients:

Isopropyl Alcohol >/= 70.1%

Inactive Ingredients:
Water, Betaine Anhydrous, Anionic Water Soluble Polymer,
Amino Methyl Propanol, DL Alpha Tocopherol Acetate

For external use only. Flammable. Keep away from heat or flame

Use[s] • Hand sanitizer to help reduce bacteria that potentially
can cause disease.

Do not use
• in children less than 2 months of age
• on open skin wounds

For use when soap and water are not
available.

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
• Place enough product on hands to cover all surfaces. Rub
hands together until dry.
• Supervise children under 6 years of age when using this
product to avoid swallowing

Other information
• Store between 59-86F (15-30C)
• Avoid freezing and excessive heat above 140F (40C)

16 oz Bottle

32 oz Bottle

Case

HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74689-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70.1 mL  in 70.1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
BETAINE (UNII: 3SCV180C9W)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74689-000-32946 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/03/2020
2NDC:74689-000-16473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/03/2020
Labeler - Maryland Correctional Enterprises (021961458)
Establishment
NameAddressID/FEIBusiness Operations
Maryland Correctional Enterprises021961458manufacture(74689-000)

Revised: 4/2020
Document Id: a472a0d0-c726-9cdb-e053-2a95a90a076f
Set id: a26956c4-96fa-b8e9-e053-2a95a90a3cb8
Version: 2
Effective Time: 20200429
 
Maryland Correctional Enterprises