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

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Guard Rx Hand Sanitizer Red Thyme Oil

Active Ingredients:

Ethanol 62%

Purpose:

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 a doctor if redness and irritation develop and persist for more than 72 hours.

-Keep our 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.

Active Ingredients:

Ethanol 62%

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 a doctor if redness and irritation develop and persist for more than 72 hours.

-Keep our 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.

Active Ingredients:

Ethanol 62%

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 a doctor if redness and irritation develop and persist for more than 72 hours.

-Keep our 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: 74306-123-02

red thyme 59 ml label

118 mL NDC: 74306-123-04

118 ml label

236 mL NDC: 74306-123-08

236 ml label

59 mL NDC: 74306-124-02

59 ml label

118 mL NDC: 74306-124-04

118 ml label

236 mL NDC: 74306-124-08

236 ml label

59 mL NDC: 74306-125-02

59 ml label

118 mL NDC: 74306-125-04

118 ml label

236 mL NDC: 74306-125-08

236 ml label

GUARDRX RED THYME 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ORANGE OIL (UNII: AKN3KSD11B)  
WATER (UNII: 059QF0KO0R)  
THYME OIL (UNII: 2UK410MY6B)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74306-123-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
2NDC:74306-123-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
3NDC:74306-123-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2020
GUARDRX LAVENDER PEPPERMINT 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-124
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74306-124-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
2NDC:74306-124-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
3NDC:74306-124-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2020
GUARDRX UNSCENTED 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74306-125-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
2NDC:74306-125-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
3NDC:74306-125-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2020
Labeler - GPS Associates (096942063)
Registrant - GPS Associates, LLC (096942063)
Establishment
NameAddressID/FEIBusiness Operations
GPS Associates096942063manufacture(74306-123, 74306-124, 74306-125)

Revised: 3/2020
Document Id: a1cb21f4-f3fa-365f-e053-2a95a90a23f4
Set id: a1cb21f4-f3f9-365f-e053-2a95a90a23f4
Version: 1
Effective Time: 20200326
 
GPS Associates