NDC 42129-018 Alcohol Wipes 75%

Alcohol Wipes 75%

NDC Product Code 42129-018

NDC 42129-018-01

Package Description: 50 CLOTH in 1 BAG

NDC Product Information

Alcohol Wipes 75% with NDC 42129-018 is a a human over the counter drug product labeled by Fustin (xiamen) Commodity Co., Ltd.. The generic name of Alcohol Wipes 75% is alcohol wipes 75%. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Fustin (xiamen) Commodity 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.

Alcohol Wipes 75% 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 g/1001

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.

  • LONICERA HYPOGLAUCA WHOLE (UNII: V0QHS0RH24)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Fustin (xiamen) Commodity Co., Ltd.
Labeler Code: 42129
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: 03-30-2020 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.

Alcohol Wipes 75% Product Label Images

Alcohol Wipes 75% 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)

ETHANOL ALCOHOL 75%

Purpose

Antiseptic

Use

SINGLE USE WIPES TO ClEAN & REMOVEA LLERGENS.

Warnings

FOR EXTERNAL USE ONLY. DO NOT REPLACE WIIPES USED FOR MEDICAL PROCEDURES. THESE WIPES ARE MEANT FOR GENERAL CLEANSING.FLAMMABLE KEEP AWAY FROM FIRE OR FLAME. IF EYES CONTACT OCCURS, FLUSIH EYES WITH WATER.STORE AT ROOM TEMPERATURE 59F - 86F.

Otc - Keep Out Of Reach Of Children

·Keep out of reach of crildren.lf swallowed get medical help or contact a Poison Control Center right away.

Otc - When Using

When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water.Stop use and ask a doctor if irritation and redness develop and persist.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

DO NOT REPLACE WIIPES USED FOR MEDICAL PROCEDURES. THESE WIPES ARE MEANT FOR GENERAL CLEANSING.

Storage And Handling

STORE AT ROOM TEMPERATURE 59F - 86F.

Inactive Ingredients

WATER, ALOE VERA EXTRACT,HONEVSUCKLE EXTRACT

Dosage & Administration

FLAMMABLE KEEP AWAY FROM FIRE OR FLAME. IF EYES CONTACT OCCURS, FLUSIH EYES WITH WATER.

Otc - Stop Use

STOP USE: IF IRRITATION AND REDNESS DEVELOP. IF C·ONDITl10N CONTINUES, CONSULT YOUR HEALTH CARE PRACTITIONER.

* Please review the disclaimer below.