FDA.reportPublic FDA data

BluZen - Winter Pine, Wintermint, Peppermint - Kit

Manufacturer
Remcoda, Llc
Effective date
2020-09-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:23

Label at a glance#

ProductBluZen - Winter Pine, Wintermint, Peppermint - Kit
Active ingredientALCOHOL
Label structure32 sections

Dosage and administration

■ 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

Storage and handling

■ Store below 104°F (40°C)

Label contents#

Full prescribing information#

BLUZEN HAND SANITIZER WINTER PINE

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses ■ hand sanitizer to help reduce bacteria on skin

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

STORAGE AND HANDLING SECTION

■ Store below 104°F (40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, aloe barbadensis leaf juice, glycerin, fragrance

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses ■ hand sanitizer to help reduce bacteria on skin

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

STORAGE AND HANDLING SECTION

■ Store below 104°F (40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, aloe barbadensis leaf juice, glycerin, fragrance

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses ■ hand sanitizer to help reduce bacteria on skin

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

STORAGE AND HANDLING SECTION

■ Store below 104°F (40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, aloe barbadensis leaf juice, glycerin, fragrance

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KIT LABELKIT LABEL

KIT COMPONENTS LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KIT COMPONENTS LABELKIT COMPONENTS LABELKIT COMPONENTS LABELKIT COMPONENTS LABELKIT COMPONENTS LABELKIT COMPONENTS LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
582753ethanol 70 % Topical SolutionPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
581662ethanol 70 % Topical GelSY1
582753ethanol 70 % Topical SolutionSY1
581662ethyl alcohol 70 % Topical GelSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79200-705-022022-01-28C16284748780-1d6a99b39-60d6-a426-e053-dadaa90af4c2BLUZEN HAND SANITIZER KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79200-605-02BluZen - Winter Pine, Wintermint, Peppermint - Kit60 mL in 1 BOTTLE, PUMPLIQUID60 mL70 mL in 100mL1
79200-606-02BluZen - Winter Pine, Wintermint, Peppermint - Kit60 mL in 1 BOTTLE, PUMPLIQUID60 mL70 mL in 100mL1
79200-607-16BluZen - Winter Pine, Wintermint, Peppermint - Kit60 mL in 1 BOTTLE, PUMPLIQUID60 mL70 mL in 100mL1
79200-705-02BluZen - Winter Pine, Wintermint, Peppermint - Kit1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79200-605BLUZEN - WINTER PINE, WINTERMINT, PEPPERMINT - KIT (ETHYL ALCOHOL) KIT [REMCODA, LLC]1Legacy NDC20200916_74f5555a-22fa-4f84-bf5a-28015d05dc02.zip
79200-606BLUZEN - WINTER PINE, WINTERMINT, PEPPERMINT - KIT (ETHYL ALCOHOL) KIT [REMCODA, LLC]1Legacy NDC20200916_74f5555a-22fa-4f84-bf5a-28015d05dc02.zip
79200-607BLUZEN - WINTER PINE, WINTERMINT, PEPPERMINT - KIT (ETHYL ALCOHOL) KIT [REMCODA, LLC]1Legacy NDC20200916_74f5555a-22fa-4f84-bf5a-28015d05dc02.zip
79200-705BLUZEN - WINTER PINE, WINTERMINT, PEPPERMINT - KIT (ETHYL ALCOHOL) KIT [REMCODA, LLC]1Legacy NDC, 4 package rows20200916_74f5555a-22fa-4f84-bf5a-28015d05dc02.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79200-70579200-705-02
79200-60579200-605-02
79200-60679200-606-02
79200-60779200-607-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
50f125a3-3bbe-44d5-b965-355fc56ff45974f5555a-22fa-4f84-bf5a-28015d05dc022020-09-11WarningsExact identifier
spl id: 50f125a3-3bbe-44d5-b965-355fc56ff459
spl set id: 74f5555a-22fa-4f84-bf5a-28015d05dc02

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.