NDC 78055-010 Wet Wipes

Wet Wipes

NDC Product Code 78055-010

NDC 78055-010-01

Package Description: 70 PATCH in 1 PAIL > 6.5 g in 1 PATCH

NDC Product Information

Wet Wipes with NDC 78055-010 is a a human over the counter drug product labeled by Dalian Oupai Technology Co.,ltd.. The generic name of Wet Wipes is wet wipes. The product's dosage form is patch and is administered via topical form.

Labeler Name: Dalian Oupai Technology Co.,ltd.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

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.

  • BENZALKONIUM CHLORIDE .13 g/100g

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BETAINE (UNII: 3SCV180C9W)
  • CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: Dalian Oupai Technology Co.,ltd.
Labeler Code: 78055
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: 09-28-2020 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: 12-31-2021 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.

Wet Wipes Product Label Images

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

Active Ingredients

Benzalkonium Chloride 0.13%  . Purpose: Antiseptic/Hand & Skin Sanitizer

Otc - When Using

USES Sanitizing Hand Wipes to help decrease bacteria on the skin.Recommended for single use.

Otc - Stop Use

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Otc - Keep Out Of Reach Of Children

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

Directions For Use:

Wipe liberally over the hands & body,rub into skin until dry.Recommended for single use.

Inactive Ingredients

Water(Aqua),Glycerol,Propanediol,Aloe Vera Extrat, Amino acid moisturizer,Hexadecylpyridinium Chloride,Chlorphenesin,Vitamin E,Dodecyl polyglucoside,Citric acid,Sodium citrate.

Purpose

Antiseptic/hand & Skin sanitizer

Uses

USES Sanitizing Hand Wipes to help decrease bacteria on the skin.Recommeded for single use.

Warning

Do not freeze.For external use only,Store at room temperature.Do not use in ears,eyes or mouth.Avoid contact with the eyes.In case of contact,flush eyes with water.Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.Keep out of reach of children.Children should be supervised when using this product.If swallowed, get medical help or contact Poison Control Centre immediately.

* Please review the disclaimer below.