NDC 55415-008 1000 Wet Wipes

1000 Wet Wipes

NDC Product Code 55415-008

NDC 55415-008-01

Package Description: 1000 CLOTH in 1 PACKET

NDC Product Information

1000 Wet Wipes with NDC 55415-008 is a a human over the counter drug product labeled by Jiangsu Meifan Biotechnology Co., Ltd.. The generic name of 1000 Wet Wipes is 1000 wet wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Jiangsu Meifan Biotechnology 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.

1000 Wet 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.

  • ISOPROPYL ALCOHOL 2.82 kg/10001

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • CHAMOMILE (UNII: FGL3685T2X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • 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.
  • 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: Jiangsu Meifan Biotechnology Co., Ltd.
Labeler Code: 55415
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: 11-09-2020 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.

1000 Wet Wipes Product Label Images

1000 Wet 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

Otc - Active Ingredient

Lsopropyl Alcohol - 75% v/v (Antimicrobial)

Inactive Ingredient

Aloe Vera Leaf, Chamomile,Propylene Glycol,Tocopherol, Water

Uses

Hand sanitizer to decrease bacteria on the skin.Recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Otc - Purpose

Disinfection

Sterilization

No Rinseing

Otc - Do Not Use

Do not use in or near the eyes. lf contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

Rash or irritation develops and lasts more than 24 hrs.

Otc - Keep Out Of Reach Of Children

Lf swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Rub hands thoroughly with product.Rub hands together until dry.

Children under 6 years of age should be supervised when using this product.

Other Information

Store at room temperature 68°F to 77°F(20° to 25°C).Do not expose to heat oropen flame. May discolor certain fabrics.

* Please review the disclaimer below.