NDC 79366-101 Luck-lady Alcohol Wipes

75% Alcohol Wipes

NDC Product Code 79366-101

NDC 79366-101-01

Package Description: 5.2 g in 1 POUCH

NDC 79366-101-10

Package Description: 52 g in 1 POUCH

NDC 79366-101-25

Package Description: 130 g in 1 POUCH

NDC 79366-101-50

Package Description: 260 g in 1 POUCH

NDC Product Information

Luck-lady Alcohol Wipes with NDC 79366-101 is a a human over the counter drug product labeled by Dong Hiep Trading And Investment Co., Ltd. The generic name of Luck-lady Alcohol Wipes is 75% alcohol wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Dong Hiep Trading And Investment Co., Ltd

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Luck-lady Alcohol Wipes 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 75 g/100g

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)

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: Dong Hiep Trading And Investment Co., Ltd
Labeler Code: 79366
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: 07-03-2020 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.

Luck-lady Alcohol Wipes 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

Otc - Active Ingredient

Alcohol 75%

Inactive Ingredient

Purified water

Otc - Purpose

Sanitizer

Indications & Usage

Open the lid, take off the sticker inside, remove each piece to use.After using, close the lid to keep moist and prevent bacteria.

Warnings

  • This product is not edible.Please wait until the alcohol has completely evaporarted after wiping.It is single use product and cannot be reused.Before use, check whether the packaging is intact. Do not use if it is damaged.Do not wipe eyes and damaged skin areas.Keep this product out of the reach of infants and children to avoid accident.This product is not water-soluble, please do not throw it into the toilet.Keep away from fire.For those with alcohol allergy or sensitive skin, please use with caution.* Result from laboratory products achieved antibacterial efficiency of 99.9% of the microorganisms Staphylococcus
  • Aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans fungi.

Otc - When Using

Open the lid, take of the sticker inside, remove each piece to use.

After using, close the lid to keep moist and prevent bacteria.

Please wait until the alcohol has completely evaporarted after wiping.Before use, check whether the packaging is intact. Do not use if it is damaged.

Otc - Do Not Use

Keep away from fire,

Do not wipe your eyes.

Do not throw into the toilet (not soluble in water)

Otc - Stop Use

Stop use and ask a doctor for those with alcohol allergy or sensitive skin.

Otc - Keep Out Of Reach Of Children

Keep this product out of the reach of infants and children to avoid accident.

Storage And Handling

Storage: Please store in a cool place, avoid sunlight or high temperature.

Date of manufacture: marked on the packaging bag.

Date of expiry: 3 years.

Recent Major Changes

Released

Dosage & Administration

It is single use product and cannot be reused.

* Please review the disclaimer below.