NDC 82222-001 Desmaquillante Ojos Weye

Makeup Remover

NDC Product Code 82222-001

NDC 82222-001-01

Package Description: 1 U in 1 BOTTLE, DISPENSING

NDC Product Information

Desmaquillante Ojos Weye with NDC 82222-001 is a a human over the counter drug product labeled by Weye Laboratory Group S.l.. The generic name of Desmaquillante Ojos Weye is makeup remover. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Desmaquillante Ojos Weye 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.


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.

  • LACTIC ACID (UNII: 33X04XA5AT)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • WATER (UNII: 059QF0KO0R)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
  • ALLANTOIN (UNII: 344S277G0Z)
  • SODIUM LEVULINATE (UNII: VK44E1MQU8)
  • SODIUM ANISATE (UNII: F9WFJ28MV9)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • MALTOOLIGOSYL GLUCOSIDE (UNII: N91S91EFOG)
  • HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
  • PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
  • MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP)

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: Weye Laboratory Group S.l.
Labeler Code: 82222
FDA Application Number: part349 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-07-2021 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.

Desmaquillante Ojos Weye 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

ACTIVE INGREDIENT

Purpose

PURPOSE AND USES

Warnings And Precaution

WARNINGS AND PRECAUTION

Warnings

WARNINGS

Ask Doctor

ASK DOCTOR

Keep Out

KEEP OUT

Questions

QUESTIONS

Pregnancy

PREGNANCY WARNING

Indications

Indications

Dosage

Dosage

Inactive Ingredients

Inactive ingredients

Indications And Usage

Indications and usage

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