NDC 79200-301 Bluzen Hand Sanitizer Kit

Ethyl Alcohol

NDC Product Code 79200-301

NDC 79200-301-02

Package Description: 1 KIT in 1 KIT * 60 mL in 1 BOTTLE, SPRAY (79200-202-02) * 60 mL in 1 BOTTLE, SPRAY (79200-203-02) * 60 mL in 1 BOTTLE, SPRAY (79200-201-02)

NDC Product Information

Bluzen Hand Sanitizer Kit with NDC 79200-301 is a a human over the counter drug product labeled by Remcoda, Llc. The generic name of Bluzen Hand Sanitizer Kit is ethyl alcohol. The product's dosage form is kit and is administered via form.

Labeler Name: Remcoda, Llc

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAVANDIN OIL (UNII: 9RES347CKG)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remcoda, Llc
Labeler Code: 79200
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-02-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Bluzen Hand Sanitizer Kit Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Bluzen Hand Sanitizer-Lavender

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Ethyl alcohol 70% v/v

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Antiseptic

Antiseptic

Uses

  • Hand sanitizer to help reduce bacteria on skin

  • Hand sanitizer to help reduce bacteria on skin

  • Hand sanitizer to help reduce bacteria on skin

Warnings

Flammable, keep away from fire/flameFor external use onlyWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water • do not inhale or ingestStop use and ask a doctor if irritation and redness develop

Flammable, keep away from fire/flameFor external use onlyWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water • do not inhale or ingestStop use and ask a doctor if irritation and redness develop

Flammable, keep away from fire/flameFor external use onlyWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water • do not inhale or ingestStop use and ask a doctor if irritation and redness develop

Otc - Keep Out Of Reach Of Children

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

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

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

  • Wet hands thoroughly with product and allow to dry without wipingsupervise children under 6 years of age when using this product to avoid swallowing

  • Wet hands thoroughly with product and allow to dry without wipingsupervise children under 6 years of age when using this product to avoid swallowing

Other Information

  • Store below 104ºF (40ºC)

  • Store below 104ºF (40ºC)

  • Store below 104ºF (40ºC)

Inactive Ingredients

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

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

Water, aloe barbadensis leaf juice, glycerin, fragrance

Questions?

1-800-777-1603

1-800-777-1603

1-800-777-1603

Bluzen Hand Sanitizer-Mint

Drug Facts

Bluzen Hand Sanitizer-Lemon

Drug Facts

* Please review the disclaimer below.