STERILEMAX HAND SANITIZER- alcohol gel 
Pure-chem, 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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STERILEMAX HAND SANITIZER

Drug Facts

Active ingredient[s]

Alcohol 70% v/v

Purpose

Antiseptic

Use[s]

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 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

• 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 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
• Store in a well ventilated place

Inactive ingredients

Acrylates, Benzophenone, Water, Glycerin, Fragrance, Carbomer, Vitamin E, Denatonium Benzoate, Diisopropylamine

LEMON FRESH

KILLS 99.99% OF GERMS*

70% ALCOHOL - REFRESHING GEL

*Effective at eliminating 9.99% of many common harmful germs and bacteria

STERILE MAX.COM

Dispose of contents/container in accordance with local/regional/national/international regulations.
See SDS for Additional Information.
Distributed by Pure-Chem LLC
Manufactured in St. Louis, MO

Packaging

IMAGE

STERILEMAX HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79325-870
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
BENZOPHENONE (UNII: 701M4TTV9O)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79325-870-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/14/2020
Labeler - Pure-chem, Llc (117559894)

Revised: 10/2020
Document Id: 2dfe1019-df26-419b-83f1-e0dae5853f35
Set id: b2606b67-889f-4ff1-85b8-fce74a1739c5
Version: 1
Effective Time: 20201014
 
Pure-chem, Llc