NDC 79544-301 Doctorpnb Hand Sanitizer

Alcohol

NDC Product Code 79544-301

NDC 79544-301-01

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC Product Information

Doctorpnb Hand Sanitizer with NDC 79544-301 is a a human over the counter drug product labeled by Pnb Lifehealth Co., Ltd.. The generic name of Doctorpnb Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Pnb Lifehealth Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Doctorpnb 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.

  • ALCOHOL 70 mL/100mL

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)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Pnb Lifehealth Co., Ltd.
Labeler Code: 79544
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: 07-12-2020 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.

Doctorpnb Hand Sanitizer Product Label Images

Doctorpnb 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

​alchol70%

Purpose

Antiseptic

Inactive Ingredient

Carbomer, water,triethanolamine, isocyanate polymer, polyacrylic acid

Direction

Apply adequate amount over hands then gently pat until it dry.

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not avaliable.

Warnings

Disontinue use amd consult a doctor following symptoms occur irritation or inflamation allergic symptoms.do not use into eyes, if contact occurs, rinse eyes throughly with water and consult doctor

Keep Out Of Reach Of Children

If swallowed contact your doctor immediately

Stop Use And Ask A Doctor

If the following symptoms appear,Stop use and immediately consult a doctor: rash, erythema, itching, edema or any other skin irritation.

Other Information

Keep container upright. Store at room temperature (1-30'C)keep away from heat and fire

Indication

After use, properly close the product to avoid drying out or spilling.Take an appropriate amount on your hands and rub thoroughly to dry.

79544-301-01

79544-301-01

* Please review the disclaimer below.