BLUZEN - WINTER PINE, WINTERMINT, PEPPERMINT - KIT- ethyl alcohol kit

BluZen - Winter Pine, Wintermint, Peppermint - Kit by

Drug Labeling and Warnings

BluZen - Winter Pine, Wintermint, Peppermint - Kit by is a Otc medication manufactured, distributed, or labeled by Remcoda, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLUZEN HAND SANITIZER WINTER PINE

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

INDICATIONS & USAGE

Uses ? hand sanitizer to help reduce bacteria on skin

Warnings

Flammable, keep away from fire/flame

For external use only

When using this product ? do not get into eyes. In case of contact, rinse eyes thoroughly with water

? do not inhale or ingest

Stop use and ask a doctor if irritation and redness develop

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

? wet hands thoroughly with product and allow to dry without wiping

? supervise children under 6 years of age when using this product to avoid swallowing

Other information

? Store below 104°F (40°C)

Inactive ingredients

water, aloe barbadensis leaf juice, glycerin, fragrance

QUESTIONS

Questions? 1-800-777-1603

SPL UNCLASSIFIED SECTION

MOISTURIZING FORMULA WITH ALOE VERA

KILLS 99.9% OF GERMS

SULFATE FREE PARABEN FREE VEGAN, CRUELTY FREE

MADE IN THE USA

Distributed by: Remcoda, LLC, New York, NY, 10018

SHOPBLUZEN.COM

BLUZEN HAND SANITIZER PEPPERMINT

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

INDICATIONS & USAGE

Uses ? hand sanitizer to help reduce bacteria on skin

Warnings

Flammable, keep away from fire/flame

For external use only

When using this product ? do not get into eyes. In case of contact, rinse eyes thoroughly with water

? do not inhale or ingest

Stop use and ask a doctor if irritation and redness develop

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

? wet hands thoroughly with product and allow to dry without wiping

? supervise children under 6 years of age when using this product to avoid swallowing

Other information

? Store below 104°F (40°C)

Inactive ingredients

water, aloe barbadensis leaf juice, glycerin, fragrance

QUESTIONS

Questions? 1-800-777-1603

SPL UNCLASSIFIED SECTION

MOISTURIZING FORMULA WITH ALOE VERA

KILLS 99.9% OF GERMS

SULFATE FREE PARABEN FREE VEGAN, CRUELTY FREE

MADE IN THE USA

Distributed by: Remcoda, LLC, New York, NY, 10018

SHOPBLUZEN.COM

BLUZEN HAND SANITIZER WINTERMINT

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

INDICATIONS & USAGE

Uses ? hand sanitizer to help reduce bacteria on skin

Warnings

Flammable, keep away from fire/flame

For external use only

When using this product ? do not get into eyes. In case of contact, rinse eyes thoroughly with water

? do not inhale or ingest

Stop use and ask a doctor if irritation and redness develop

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

? wet hands thoroughly with product and allow to dry without wiping

? supervise children under 6 years of age when using this product to avoid swallowing

Other information

? Store below 104°F (40°C)

Inactive ingredients

water, aloe barbadensis leaf juice, glycerin, fragrance

QUESTIONS

Questions? 1-800-777-1603

SPL UNCLASSIFIED SECTION

MOISTURIZING FORMULA WITH ALOE VERA

KILLS 99.9% OF GERMS

SULFATE FREE PARABEN FREE VEGAN, CRUELTY FREE

MADE IN THE USA

Distributed by: Remcoda, LLC, New York, NY, 10018

SHOPBLUZEN.COM

KIT LABEL

KIT COMPONENTS LABEL

INGREDIENTS AND APPEARANCE

BLUZEN - WINTER PINE, WINTERMINT, PEPPERMINT - KIT 
ethyl alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79200-705

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79200-705-02	1 in 1 KIT; Type 0: Not a Combination Product	09/11/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PUMP	60 mL
Part 2	1 BOTTLE, PUMP	60 mL
Part 3	1 BOTTLE, PUMP	60 mL

Part 1 of 3

BLUZEN HAND SANITIZER WINTER PINE 
ethyl alcohol liquid

Product Information
Item Code (Source)	NDC: 79200-605
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79200-605-02	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/11/2020

Part 2 of 3

BLUZEN HAND SANITIZER PEPPERMINT 
ethyl alcohol liquid

Product Information
Item Code (Source)	NDC: 79200-606
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79200-606-02	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/11/2020

Part 3 of 3

BLUZEN HAND SANITIZER WINTERMINT 
ethyl alcohol liquid

Product Information
Item Code (Source)	NDC: 79200-607
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79200-607-16	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/11/2020

Labeler - Remcoda, Llc (117130169)