NDC 77845-100 Surf Sani All-purpose Wipes

Benzalkonium Chloride

NDC Product Code 77845-100

NDC 77845-100-01

Package Description: 4 BAG in 1 CARTON > 1000 PACKAGE in 1 BAG > 3.15 mL in 1 PACKAGE

NDC 77845-100-02

Package Description: 12 PACKET in 1 CARTON > 160 PACKAGE in 1 PACKET > 3.15 mL in 1 PACKAGE

NDC 77845-100-03

Package Description: 4 BAG in 1 CARTON > 1500 PACKAGE in 1 BAG > 3.15 mL in 1 PACKAGE

NDC 77845-100-04

Package Description: 4 BAG in 1 CARTON > 800 PACKAGE in 1 BAG > 3.15 mL in 1 PACKAGE

NDC 77845-100-05

Package Description: 12 PACKET in 1 CARTON > 100 PACKAGE in 1 PACKET > 3.15 mL in 1 PACKAGE

NDC Product Information

Surf Sani All-purpose Wipes with NDC 77845-100 is a a human over the counter drug product labeled by Enviro Science Technology Inc. The generic name of Surf Sani All-purpose Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Enviro Science Technology Inc

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.

Surf Sani All-purpose 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.

  • BENZALKONIUM CHLORIDE .13 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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Enviro Science Technology Inc
Labeler Code: 77845
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: 12-28-2020 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: 12-31-2022 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.

Surf Sani All-purpose Wipes Product Label Images

Surf Sani All-purpose 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 Ingredient[S]

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use[S]

  • For Personal Hand Hygiene to help prevent the spread of bacteria.Use when soap and water are not available after changing diapers, assisting ill persons, and before contact with a person under medical care or treatment.Recommended for repeat use.

Warnings

For external use only.Do not use• Do not use in the eyes.When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or redness develops. In condition persists for more than 72 hours consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

• Wet hands thoroughly with product and allow to dry.• Supervise children under 6 years of age when using this product.

Other Information

• Store in a cool dry place

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E)

* Please review the disclaimer below.