NDC 77560-010 Flawless Hand Sanitizer

Propolis Extract

NDC Product Code 77560-010

NDC 77560-010-01

Package Description: 250 mL in 1 BOTTLE, SPRAY

NDC Product Information

Flawless Hand Sanitizer with NDC 77560-010 is a a human over the counter drug product labeled by Nbio Co., Ltd.. The generic name of Flawless Hand Sanitizer is propolis extract. The product's dosage form is spray and is administered via topical form.

Labeler Name: Nbio Co., Ltd.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Flawless Hand Sanitizer Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PROPOLIS WAX 1.25 g/250mL

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)
  • SODIUM SILICATE (UNII: IJF18F77L3)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Nbio Co., Ltd.
Labeler Code: 77560
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-01-2020 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.

Flawless Hand Sanitizer Product Label Images

Flawless Hand Sanitizer 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

Active Ingredient

Propolis Extract 0.5%

Inactive Ingredients

Water, Sodium Silicate

Purpose

Sanitizer

Warnings

■ For external use only.--------------------------------------------------------------------------------------------------------When using this product■ Do not use in or near the eyes. In case of contact, rinse eyes thoroughlywith water.■ Avoid contact with broken skin.■ Do not inhale or ingest.--------------------------------------------------------------------------------------------------------Stop use and ask a doctor■ If irritation or rash appears and lasts.

Keep Out Of Reach Of Children

■ If swallowed, get medical help or contact a Poison Control Center right away

Uses

■ Hand sanitizer to help reduce bacteria that potentially can cause disease.■ For use when soap and water are not available.

Directions

■ Please spray it at a distance of 10~20cm so that your hands are enough covered. Rub hands together until dry.■ Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

■ Store between 41~86℉(Between 5~30℃)■ Avoid freezing and excessive heat above 104℉(40℃) and direct sunlight.

Questions

■ www.nbio.kr / 82-31-432-5670

* Please review the disclaimer below.