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

----------

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.

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.

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.

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

Inactive Ingredients:

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

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.

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

Inactive Ingredients:

Aqua, Glycerin, Tocopherol.

59 mL NDC: 74306-133-02

GuardRx Red Thyme Extra Strength 2oz 70

118 mL NDC: 74306-133-04

GuardRx Red Thyme Extra Strength 4oz 70

236 mL NDC: 74306-133-08

GuardRx Red Thyme Extra Strength 8oz 70

59 mL NDC: 74306-134-02

GuardRx Lavender Peppermint 2oz 70

118 mL NDC: 74306-134-04

GuardRx Lavender Peppermint 4oz 70

236 mL NDC: 74306-134-08

GuardRx Lavender Peppermint 8oz 70

59 mL NDC: 74306-135-02

GuardRx Unscented 2oz 70

118 mL NDC: 74306-135-04

GuardRx Unscented 4oz 70

236 mL NDC: 74306-135-08

GuardRx Unscented 8oz 70

GUARDRX UNSCENTED EXTRA STRENGTH 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74306-135-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
2NDC:74306-135-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
3NDC:74306-135-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/04/2020
GUARDRX LAVENDER PEPPERMINT EXTRA STRENGTH 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-134
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74306-134-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
2NDC:74306-134-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
3NDC:74306-134-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/04/2020
GUARDRX RED THYME EXTRA STRENGTH 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
THYME OIL (UNII: 2UK410MY6B)  
ORANGE OIL (UNII: AKN3KSD11B)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74306-133-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
2NDC:74306-133-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
3NDC:74306-133-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/04/2020
Labeler - GPS Associates (096942063)
Registrant - GPS Associates, LLC (096942063)
Establishment
NameAddressID/FEIBusiness Operations
GPS Associates096942063manufacture(74306-133, 74306-134, 74306-135)

Revised: 5/2020
Document Id: a4d60abf-8baa-d63a-e053-2995a90a7427
Set id: a4874b8b-d4ce-dbcc-e053-2995a90afcb7
Version: 2
Effective Time: 20200504
 
GPS Associates