NDC 68605-2010 End-zit

Sulfur

NDC Product Code 68605-2010

NDC Product Information

End-zit with NDC 68605-2010 is a a human over the counter drug product labeled by Abbe Laboratories, Inc.. The generic name of End-zit is sulfur. The product's dosage form is lotion, augmented and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1094323 and 422938.

Dosage Form: Lotion, Augmented - A lotion dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented".

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.

End-zit 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.


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: Abbe Laboratories, Inc.
Labeler Code: 68605
FDA Application Number: part333D 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: 04-20-2004 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".

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End-zit Product Label Images

End-zit 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

Indications & Usage

Intended for use on blemishes only. This advanced formulation is designed to dry and aid in elimination of pimples. It is make-up quality for excellent coverage of the blemish. It is unbelievably effective, clinically tested, dermatologist approved and recommended.

Dosage & Administration

DIRECTIONS: Shake bottle well before each use. Apply directly to blemish only, using applicator. Wait a few moments until slightly dry. Pat with fingertip or clean cotton swab to blend color to skin. Make-up may be applied if desired. Should remain on skin all day. Re-apply at night to clean skin to remain on skin overnight.

Otc - Do Not Use

NOTE: PERSONS WITH KNOWN SENSITIVITY TO SULFUR SHOULD AVOID USE OF THIS PRODUCT.KEEP FROM EYES.

Otc - Active Ingredient

DRUG  FACTSACTIVE INGREDIENT ............  SULFUR 5%

Otc - Purpose

PURPOSE    .............    ACNE TREATMENT

Warnings

WARNINGS:• For external use only.• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.• Do not get into eyes. If excessive skin irritation deve lops or increases, discontinue use and consult a doctor.

Otc - Keep Out Of Reach Of Children

• Keep out of reach of children.

Inactive Ingredient

OTHER INGREDIENTS: Isopropyl Alcohol, Water, Zinc Oxide, Propylene Glycol, Camphor, Talc, Sodium Laureth Sulfate, Titanium Dioxide, Diazolidinyl Urea, Methylparaben, Propylparaben. May contain Iron Oxides.NDC #'sLight/Medium 68605-2001-2       Medium/Dark 68605-2002-2Sun Bronze 68605-2003-2                  Untinted 68605-2006-2

* Please review the disclaimer below.