FDA.reportPublic FDA data

BluZen Hand Sanitizer Kit

Manufacturer
Remcoda, Llc
Effective date
2020-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:33

Label at a glance#

ProductBluZen Hand Sanitizer Kit
Active ingredientALCOHOL
Label structure32 sections

Indications and uses

hand sanitizer to help reduce bacteria on skin

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 104ºF (40ºC)

Label contents#

Full prescribing information#

BluZen Hand Sanitizer-Lavender

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • 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 104ºF (40ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, aloe barbadensis leaf juice, glycerin, lavandula hybrida (lavandin) oil

Questions?

OTC - QUESTIONS SECTION

1-800-777-1603

SPL UNCLASSIFIED SECTION

MOISTURIZING FORMULA WITH ALOE VERA

LAVENDER

KILLS 99.9% OF GERMS

SHOPBLUZEN.COM

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

SULFATE FREE * PARABEN FREE * VEGAN, CRUELTY FREE * MADE IN THE USA

BluZen Hand Sanitizer-Mint

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • 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 104ºF (40ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, aloe barbadensis leaf juice, glycerin, mentha piperita (peppermint) oil

Questions?

OTC - QUESTIONS SECTION

1-800-777-1603

SPL UNCLASSIFIED SECTION

MOISTURIZING FORMULA WITH ALOE VERA

MINT

KILLS 99.9% OF GERMS

SHOPBLUZEN.COM

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

SULFATE FREE * PARABEN FREE * VEGAN, CRUELTY FREE * MADE IN THE USA

BluZen Hand Sanitizer-Lemon

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • 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 104ºF (40ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, aloe barbadensis leaf juice, glycerin, fragrance

Questions?

OTC - QUESTIONS SECTION

1-800-777-1603

SPL UNCLASSIFIED SECTION

MOISTURIZING FORMULA WITH ALOE VERA

CITRUS

KILLS 99.9% OF GERMS

SHOPBLUZEN.COM

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

SULFATE FREE * PARABEN FREE * VEGAN, CRUELTY FREE * MADE IN THE USA

KIT LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

KIT COMPONENTS LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN1
1041849ethanol 0.7 ML/ML Topical SpraySCD1
1041849ethanol 70 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79200-301-022022-01-28C16284748780-1d6a99b39-aaf8-a426-e053-dadaa90af4c2BLUZEN HAND SANITIZER KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79200-201-02BluZen Hand Sanitizer Kit60 mL in 1 BOTTLE, SPRAYSPRAY60 mL70 mL in 100mL1
79200-202-02BluZen Hand Sanitizer Kit60 mL in 1 BOTTLE, SPRAYSPRAY60 mL70 mL in 100mL1
79200-203-02BluZen Hand Sanitizer Kit60 mL in 1 BOTTLE, SPRAYSPRAY60 mL70 mL in 100mL1
79200-301-02BluZen Hand Sanitizer Kit1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79200-201BLUZEN HAND SANITIZER KIT (ETHYL ALCOHOL) KIT [REMCODA, LLC]1Legacy NDC20200709_4be9d6e9-f885-40ec-9af5-63ff3f2697be.zip
79200-202BLUZEN HAND SANITIZER KIT (ETHYL ALCOHOL) KIT [REMCODA, LLC]1Legacy NDC20200709_4be9d6e9-f885-40ec-9af5-63ff3f2697be.zip
79200-203BLUZEN HAND SANITIZER KIT (ETHYL ALCOHOL) KIT [REMCODA, LLC]1Legacy NDC20200709_4be9d6e9-f885-40ec-9af5-63ff3f2697be.zip
79200-301BLUZEN HAND SANITIZER KIT (ETHYL ALCOHOL) KIT [REMCODA, LLC]1Legacy NDC, 4 package rows20200709_4be9d6e9-f885-40ec-9af5-63ff3f2697be.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
79200-30179200-301-02
79200-20179200-201-02
79200-20279200-202-02
79200-20379200-203-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
LAVANDIN OIL9RES347CKGIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
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
c3da8e11-7f5b-4e3c-a0b3-fdb995cb048b4be9d6e9-f885-40ec-9af5-63ff3f2697be2020-07-03WarningsExact identifier
spl id: c3da8e11-7f5b-4e3c-a0b3-fdb995cb048b
spl set id: 4be9d6e9-f885-40ec-9af5-63ff3f2697be

Reported adverse events (FAERS/openFDA)#

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