NDC 77822-201 Sera Hand-sanitizing Wipe

Benzalkonium Chloride

NDC Product Code 77822-201

NDC 77822-201-01

Package Description: 42 g in 1 POUCH

NDC 77822-201-02

Package Description: 280 g in 1 POUCH

NDC Product Information

Sera Hand-sanitizing Wipe with NDC 77822-201 is a a human over the counter drug product labeled by Sng Co., Ltd. The generic name of Sera Hand-sanitizing Wipe is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Sng 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.

Sera Hand-sanitizing Wipe 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.


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: Sng Co., Ltd
Labeler Code: 77822
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: 05-24-2020 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.

Sera Hand-sanitizing Wipe Product Label Images

Sera Hand-sanitizing Wipe 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 Ingredients

Benzalkonium chloride 0.1%



Inactive Ingredient

Purified water, Glycerin, Hydroxyacetophenone, Cetylpyridinium chloride, Citric acid


1. Open the cover, Pick as much as you needs, Wipe your body gently.2. Put sticker after using. There is risk of drying.3. Use it as soon as possible after opening.Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

1. Store in cool and shady place, between 15-30C (59-86F)2. May discolor certain fabrics or surfaces.

Hand Sanitizer To Hlep Reduce Bacteria

Hypoallergenic.No harmful chemicals/Refreshness from no stickness, residue after using.Keep your hands clean when it's hard to wash your hands.

Stop Use And Ask A Docotr If Signs Symptoms As Follows:

(1) signs of irritation and/or rash appears(2) signs of abnormality as above after exposed to sunlight.

Keep Out Of Reach Of Children.

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

Avoid Contact With Eyes.

In case of contact, rinse eyes thoroughly with water.

Do Not Dispose Used Tissue In The Flushing Toilet.

Do not put used tissue into pack again.There is the risk of degeneration.


Flammable. Keep away from heat or flame.Use only as intended and according to the directions of use.

* Please review the disclaimer below.