NDC 77417-002 Sani Wipes Instant Sanitizing Wipes

Alcohol

NDC Product Code 77417-002

NDC 77417-002-00

Package Description: 100 POUCH in 1 POUCH > 411 mL in 1 POUCH

NDC 77417-002-50

Package Description: 50 POUCH in 1 POUCH > 250 mL in 1 POUCH

NDC 77417-002-60

Package Description: 60 POUCH in 1 POUCH > 300 mL in 1 POUCH

NDC 77417-002-80

Package Description: 80 POUCH in 1 POUCH > 355 mL in 1 POUCH

NDC Product Information

Sani Wipes Instant Sanitizing Wipes with NDC 77417-002 is a a human over the counter drug product labeled by Tiger Packaging Corp.. The generic name of Sani Wipes Instant Sanitizing Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Tiger Packaging Corp.

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.

Sani Wipes Instant Sanitizing 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 72 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.

  • BRONOPOL (UNII: 6PU1E16C9W)
  • QUATERNIUM-24 (UNII: 0T2NG1539G)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • DIOCTYLDIMONIUM CHLORIDE (UNII: 0X0RL40Y6H)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • 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: Tiger Packaging Corp.
Labeler Code: 77417
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: 07-06-2020 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.

Sani Wipes Instant Sanitizing Wipes Product Label Images

Sani Wipes Instant Sanitizing 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

Active Ingredients

Alcohol 72% v/v

Purpose

Antiseptic

Uses

  • Sanitizing wipe to help reduce bacteria that potentially can cause disease.for use when soap and water are not available.safe for repeated use.

Warnings

For external use only.Flammable. Keep away from heat or flame.

Do Not Use

  • As a diaper wipeon children less than 2 months of ageon open skin wounds

When Using This Product

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Discontinue Use

If irritation or redness develops. If condition persists for more than 72 hours contact a doctor.

Keep Out Of Reach Of Children

Unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wipe product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store in a cool, dry place, away from direct sunlight

Inactive Ingredients

Water, Phenoxyethanol, Disodium Cocoamphodiacetate, 2-Bromo-2-Nitropropane-1, 3-Diol, Benzalkonium Chloride, Quaternium-24, Didecyldimonium Chloride, Dioctyldimonium Chloride.

Company Information

MANUFACTURED FOR:Tiger Packaging CorpBoca Raton, FL 33431Made in Vietnam

Product Packaging - 50 Pcs

SANI WIPESWITH 72% ALCOHOLInstant Sanitizing WipesPerfect For On-The-Go!50 PCS150x200mm

* Please review the disclaimer below.