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 68% 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, Carbomer, Vitamin E, Denatonium Benzoate, Water, Glycerin, Fragrance, Diisopropylamine

LEMON CITRUS FRAGRANCE

REFRESHING GEL-BASED FORMULA

MADE IN USA

DANGER: Highly Flammable liquid and vapor. Causes serious eye irritation. Keep container tightly closed. Keep out of reach of children. Keep away from heat/sparks/open flames/hot surfaces. No smoking. Use only non-sparking tools. Take precautionary measures against static discharge. May discolor certain fabrics or surfaces.

IN CASE OF FIRE: Use dry sand, dry chemical or alcohol-resistant foam to extinguish.

Dispose of contents/container in accordance with local/regional/national/international regulations.

See SDS for Additional Information.

Distributed By:

Pure-Chem LLC

www.Pure-Chem.com

Manufactured in St. Louis, MO

Packaging

Steril1

100 Pouches

IMAGE

STERILEMAX HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79325-862
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
BENZOPHENONE (UNII: 701M4TTV9O)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79325-862-011 mL in 1 POUCH; Type 0: Not a Combination Product07/01/2020
2NDC:79325-862-151.5 mL in 1 POUCH; Type 0: Not a Combination Product07/01/2020
3NDC:79325-862-04100 in 1 CONTAINER10/20/2020
3NDC:79325-862-151.5 mL in 1 POUCH; Type 0: Not a Combination Product
4NDC:79325-862-202 mL in 1 POUCH; Type 0: Not a Combination Product07/01/2020
5NDC:79325-862-252.5 mL in 1 POUCH; Type 0: Not a Combination Product07/01/2020
6NDC:79325-862-303 mL in 1 POUCH; Type 0: Not a Combination Product07/01/2020
7NDC:79325-862-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
8NDC:79325-862-0389 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
9NDC:79325-862-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
10NDC:79325-862-10296 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
11NDC:79325-862-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
12NDC:79325-862-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
13NDC:79325-862-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
14NDC:79325-862-641892 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
15NDC:79325-862-003785 mL in 1 JUG; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2020
Labeler - Pure-chem, Llc (117559894)

Revised: 10/2020
Document Id: ba579424-6984-4f7c-97dc-a1cebefa37ac
Set id: f1bf45b0-3b75-4925-a654-5f2e72cd2c98
Version: 2
Effective Time: 20201022
 
Pure-chem, Llc