GUARDRX GEL HAND SANITIZER- gel hand sanitizer gel 
GPS Associates

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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Ethanol 73%

Purpose:

Antiseptic

Uses:

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

-Flammable, keep away from fire or flame.

-For external use only.

-Do not use in eyes. If contact occurs, flush thoroughly with water.

-Stop use and ask doctor if redness and irritation develop and persist for more than 72 hours.

-Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Directions:

Wet hands thoroughly with product and allow to dry without wiping.

-Do not use other than directed.

Store at room temperature 20-25 °C (66-77 °F)

Aqua, Glycerin, Hydroxypropyl Cellulose, Triethanolamine, Hydrogen Peroxide,

59.15 mL NDC: 74306-234-02

GuardRx Gel Label 2oz

118.29 mL NDC: 74306-234-04

GuardRx Gel Label 4oz

236.58 mL NDC: 74306-234-08

Guard Rx Gel Label 8oz

499.8 mL NDC: 74306-234-16

GuardRx Gel label 16.9oz

GUARDRX GEL HAND SANITIZER 
gel hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-234
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)  
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74306-234-0259.15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
2NDC:74306-234-04118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
3NDC:74306-234-08236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
4NDC:74306-234-16499.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/21/2020
Labeler - GPS Associates (096942063)
Registrant - GPS Associates, LLC (096942063)
Establishment
NameAddressID/FEIBusiness Operations
GPS Associates096942063manufacture(74306-234)

Revised: 5/2020
Document Id: a6317d0d-2390-3a26-e053-2995a90ac7f8
Set id: a6317d0d-238f-3a26-e053-2995a90ac7f8
Version: 1
Effective Time: 20200521
 
GPS Associates