GUARDEX HAND SANITIZER ANTISEPTIC SOLUTION- isopropyl alcohol 75% liquid 
Guardex Labs, Inc.

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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Guardex Hand Sanitizer Antiseptic Topical Solution

Active Ingredient

Isopropyl Alcohol 75%

Purpose

Antiseptic

Uses

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

On 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)

Inactive Ingredients

glycerin, hydrogen peroxide, Triethanolamine, carbomer, purified water USP

Guardex Hand Sanitizer Antiseptic Topical Solution

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GUARDEX HAND SANITIZER ANTISEPTIC SOLUTION 
isopropyl alcohol 75% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80307-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL187.5 mL  in 250 mL
Inactive Ingredients
Ingredient NameStrength
TRIETHANOLAMINE TRISTEARATE (UNII: HOM72YRP1F)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
(3-BROMOPROPYL)BENZENE (UNII: 6VX623QN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80307-002-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
2NDC:80307-002-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
3NDC:80307-002-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
4NDC:80307-002-331000 mL in 1 BOTTLE; 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 - Guardex Labs, Inc. (117630183)
Registrant - Guardex Labs, Inc. (117630183)

Revised: 9/2020
Document Id: ae6d66cc-4e8b-479a-e053-2a95a90abc12
Set id: ae6d6c48-f9a8-5add-e053-2995a90a4eea
Version: 1
Effective Time: 20200903
 
Guardex Labs, Inc.