NDC 40562-018 75% Alcohol Wipes

Alcohol Wipes

NDC Product Code 40562-018

NDC 40562-018-01

Package Description: 30 PATCH in 1 PACKET > 4 mL in 1 PATCH

NDC Product Information

75% Alcohol Wipes with NDC 40562-018 is a a human over the counter drug product labeled by Anhui Hanbon Daily Chemical Co., Ltd.. The generic name of 75% Alcohol Wipes is alcohol wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Anhui Hanbon Daily Chemical 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.

75% 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 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CHAMOMILE (UNII: FGL3685T2X)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

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: Anhui Hanbon Daily Chemical Co., Ltd.
Labeler Code: 40562
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: 11-04-2020 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.

75% Alcohol Wipes Product Label Images

75% 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

Active Ingredient(S)

Ethyl Alcohol 75% v/v.

Purpose

Antiseptic

Use

  • For hand sanitizing that helps reduce bacteria on the skin.Recommended for repeated use.

Warnings

  • For external use only.Flammable, Keep away from fire or flame, heat, spark, electrical.

Do Not Use

  • On children less than 2 months of age.On open skin wounds.

Otc - When Using

  • When using this product keep out of eyes, ears, and mouth.In case of contact with eyes, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Wipe the surface of the skin and let it air dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store at room temperature.Keep pouch tightly closed and stored at room temperature.Hold away from face when opening.

Inactive Ingredients

Water, Glycerol, Propane -1,2-diol, Benzalkonium Chloride, Aloe Vera Extract, Cetylpyridinium Chloride, Didecyldimethylammonium Chloride, Tea Tree Oil, Matricaria Recutita Extract, Quaternary, Citric Acid.

* Please review the disclaimer below.