NDC 74716-010 Pure Perfect Sanitizer


NDC Product Code 74716-010

NDC 74716-010-01

Package Description: 50 mL in 1 CONTAINER

NDC 74716-010-02

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC Product Information

Pure Perfect Sanitizer with NDC 74716-010 is a a human over the counter drug product labeled by Buddy Co., Ltd.. The generic name of Pure Perfect Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Buddy Co., Ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Pure Perfect 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 g/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)

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.

Product Labeler Information

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

Labeler Name: Buddy Co., Ltd.
Labeler Code: 74716
FDA Application Number: part333E 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: 04-01-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Pure Perfect 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

Active ingredients: ALCOHOL 70.0 w%

Inactive Ingredient

Inactive Ingredients:Water, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Sodium Hyaluronate, Camellia Sinesis Leaf Extract, Morus Alba Bark Extract, Aloe Barbadensis, Leaf Extract, Olea Europaea(Olive) Fruit Oil, Tocopheryl Acetate


Purpose: Antiseptic


Warnings:1. Do not use the product on the following areas :Around the eyes and ears, in the mouth, large body part and damaged skin(it may cause irritation.)2. If you suffer from the next symptom, discontinue use of the product immediately and consult a physician or pharmacist.1) Hypersensitivity symptoms e.g. rash, erythema, itchiness, and edema2) Skin irritation symptoms3. Other precautions1) For external use only. (Do not swllow.)2) Avoid contact with eyes. If it contacts with eyes, wash with clean clean water and consult a physician or a pharmacist.3) Be careful not to inhale vapors in case of using for a long time.(In case of inhaling large amounts of ethanol vapor, it may cause irritation of the mucous membranes and headaches.)(Limited to ethanol-containing the product)4) If you use this product on the same area repeatedly, cure should be provided as the skin may become rough due to excessive oil removal.5) Do not use sealed bandages, cast bandages, or packs as they many cause irritation.6) Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns.7) Use only for the intended purpose.4. Precaution for storage1) Keep away from direct sunlight and do not expose the product to heating devices or flame.2) Let the children not touch this drug and in case of swallowing it, go to the hospital immediately.3) After use. close the lid completely and prevent the product from drying or foreign objects from getting inside the container.4) In case of keeping the product on the different container, it may cause accidents or deterioration of quality.

Keep Out Of Reach Of Children



Uses:Disinfection of hands and skin


Directions:Spray an appropriate amount on your hands and rub thoroughly to dry.

Other Information

Other information■ Read directions and precautions before use.■ Avoid freezing and excessive heat above 40℃.

* Please review the disclaimer below.