GUARDRX GEL HAND SANITIZER- gel hand sanitizer gel

GuardRx Gel Hand Sanitizer by

Drug Labeling and Warnings

GuardRx Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GPS Associates, GPS Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

59.15 mL NDC:

74306-234-02

118.29 mL NDC:

74306-234-04

236.58 mL NDC:

74306-234-08

499.8 mL NDC:

74306-234-16

INGREDIENTS AND APPEARANCE

GUARDRX GEL HAND SANITIZER 
gel hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74306-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74306-234-02	59.15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2020
2	NDC: 74306-234-04	118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2020
3	NDC: 74306-234-08	236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2020
4	NDC: 74306-234-16	499.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/21/2020

Labeler - GPS Associates (096942063)

Registrant - GPS Associates, LLC (096942063)

Establishment
Name	Address	ID/FEI	Business Operations
GPS Associates		096942063	manufacture(74306-234)