GUARDRX UNSCENTED EXTRA STRENGTH- hand sanitizer liquid GUARDRX LAVENDER PEPPERMINT EXTRA STRENGTH- hand sanitizer liquid GUARDRX RED THYME EXTRA STRENGTH- hand sanitizer liquid

GuardRx Red Thyme Extra Strength by

Drug Labeling and Warnings

GuardRx Red Thyme Extra Strength 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 70%

Purpose:

Antiseptic

Uses:

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

-Flammable, keep away from children.

-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 Ingredients:

Aqua, Glycerin, Citrus Aurantium Dulcis (Orange) Peel Oil, Thymus Vulgaris (Red Thyme) Oil, Tocopherol.

ACTIVE INGREDIENT

Ethanol 70%

Purpose:

Antiseptic

Uses:

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

-Flammable, keep away from children.

-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 Ingredients:

Aqua, Glycerin, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Tocopherol.

ACTIVE INGREDIENT

Ethanol 70%

Purpose:

Antiseptic

Uses:

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

-Flammable, keep away from children.

-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 Ingredients:

Aqua, Glycerin, Tocopherol.

59 mL NDC:

74306-133-02

118 mL NDC:

74306-133-04

236 mL NDC:

74306-133-08

59 mL NDC:

74306-134-02

118 mL NDC:

74306-134-04

236 mL NDC:

74306-134-08

59 mL NDC:

74306-135-02

118 mL NDC:

74306-135-04

236 mL NDC:

74306-135-08

INGREDIENTS AND APPEARANCE

GUARDRX UNSCENTED EXTRA STRENGTH 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74306-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74306-135-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020
2	NDC: 74306-135-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020
3	NDC: 74306-135-08	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/04/2020

GUARDRX LAVENDER PEPPERMINT EXTRA STRENGTH 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74306-134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74306-134-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020
2	NDC: 74306-134-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020
3	NDC: 74306-134-08	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/04/2020

GUARDRX RED THYME EXTRA STRENGTH 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74306-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
THYME OIL (UNII: 2UK410MY6B)
ORANGE OIL (UNII: AKN3KSD11B)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74306-133-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020
2	NDC: 74306-133-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020
3	NDC: 74306-133-08	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/04/2020

Labeler - GPS Associates (096942063)

Registrant - GPS Associates, LLC (096942063)

Establishment
Name	Address	ID/FEI	Business Operations
GPS Associates		096942063	manufacture(74306-133, 74306-134, 74306-135)