GuardRx Red Thyme: Package Insert and Label Information

GUARDRX RED THYME- alcohol liquid
GUARDRX LAVENDER PEPPERMINT- alcohol liquid
GUARDRX UNSCENTED- alcohol 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.

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 labelred thyme 59 ml label

118 mL NDC: 74306-123-04

118 ml label118 ml label

236 mL NDC: 74306-123-08

236 ml label236 ml label

59 mL NDC: 74306-124-02

59 ml label59 ml label

118 mL NDC: 74306-124-04

118 ml label118 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 label118 ml label

236 mL NDC: 74306-125-08

236 ml label236 ml label
GUARDRX RED THYME
hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74306-123
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ORANGE OIL
WATER
THYME OIL
GLYCERIN
.ALPHA.-TOCOPHEROL, DL-
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74306-123-02 59 mL in 1 BOTTLE, SPRAY None
2 NDC:74306-123-04 118 mL in 1 BOTTLE, SPRAY None
3 NDC:74306-123-08 236 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/31/2020
GUARDRX LAVENDER PEPPERMINT
hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74306-124
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
PEPPERMINT OIL
WATER
GLYCERIN
.ALPHA.-TOCOPHEROL, DL-
LAVENDER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74306-124-02 59 mL in 1 BOTTLE, SPRAY None
2 NDC:74306-124-04 118 mL in 1 BOTTLE, SPRAY None
3 NDC:74306-124-08 236 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/31/2020
GUARDRX UNSCENTED
hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74306-125
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
.ALPHA.-TOCOPHEROL, DL-
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74306-125-02 59 mL in 1 BOTTLE, SPRAY None
2 NDC:74306-125-04 118 mL in 1 BOTTLE, SPRAY None
3 NDC:74306-125-08 236 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/31/2020
Labeler — GPS Associates (096942063)
Registrant — GPS Associates, LLC (096942063)
Establishment
Name Address ID/FEI Operations
GPS Associates 096942063 manufacture (74306-123), manufacture (74306-124), manufacture (74306-125)

Revised: 03/2020 GPS Associates

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