NDC 76038-090 Meditowel Illuminating Skin Brightening

Hydroquinone

NDC Product Code 76038-090

NDC CODE: 76038-090

Proprietary Name: Meditowel Illuminating Skin Brightening What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydroquinone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin. This medicine works by blocking the process in the skin that leads to discoloration.

NDC Code Structure

  • 76038 - Micro Connection Enterprises Inc

NDC 76038-090-21

Package Description: 25 POUCH in 1 BOX > 1 mL in 1 POUCH (76038-090-01)

NDC Product Information

Meditowel Illuminating Skin Brightening with NDC 76038-090 is a a human over the counter drug product labeled by Micro Connection Enterprises Inc. The generic name of Meditowel Illuminating Skin Brightening is hydroquinone. The product's dosage form is cloth and is administered via topical form.

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.

Meditowel Illuminating Skin Brightening 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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE (UNII: V5VD430YW9)
  • ARNICA CHAMISSONIS FLOWER (UNII: 88WK5I8R3L)
  • .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Micro Connection Enterprises Inc
Labeler Code: 76038
FDA Application Number: part358A 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: 01-01-2011 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.

Meditowel Illuminating Skin Brightening 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

ACTIVE INGREDIENT (IN EACH WIPE)HYDROQUINONE 2%

Otc - Purpose

PURPOSESKIN LIGHTENER

Indications & Usage

  • USESWORKS DEEP IN THE SKIN'S SURFACE TO FADE SPOTS OVER TIME.

Warnings

WARNINGSFOR EXTERNAL USE ONLY

Otc - Stop Use

STOP AND ASK A DOCTOR IF SKIN IRRITATION BECOMES SEVERE.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Overdosage

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. POISON CONTROL CENTER # 1-800-222-1222.

Dosage & Administration

  • DIRECTIONSUNFOLD TOWELETTE COMPLETELY, APPLY TO CLEAN DRY SKIN.KEEP AWAY FROM EYES, LIPS AND MOUTH.AVOID PRODUCT CONTACT WITH HAIR AND DYED FABRICS, INCLUDING CARPETS AND CLOTHING WHICH MAY BE BLEACHED BY THIS PRODUCT.LIGHTENING EFFECT OF THIS PRODUCT MAY NOT BE NOTICEABLE WHEN USED ON VERY DARK SKIN.THIS PRODUCT MAY DARKEN OVER TIME WHICH IS NORMAL AND DOES NOT AFFECT THE PRODUCT PERFORMANCE.FOR FASTER RESULTS, EXFOLIATE 2 TO 3 TIMES A WEEK.DISCARD AFTER USE

Inactive Ingredient

INACTIVE INGREDIENTSPROPYLENE GLYCOL, GLYCERIN, WATER, ALOE VERA GEL, ARNICA EXTRACT, SODIUM METABISULFATE, ALLANTOIN, BISABOLOL, METHYLPARABEN, PROPYLPARABEN

* Please review the disclaimer below.