NDC 11118-0009 Sulfur
Soap Topical

Product Information

What is NDC 11118-0009?

The NDC code 11118-0009 is assigned by the FDA to the product Sulfur which is a human over the counter drug product labeled by Bradford Soap Works, Inc.. The product's dosage form is soap and is administered via topical form. The product is distributed in a single package with assigned NDC code 11118-0009-1 85 g in 1 carton . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code11118-0009
Proprietary Name 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.
Sulfur
Non-Proprietary Name 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.
Sulfur
Product Type 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.
Human Otc Drug
Dosage FormSoap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.
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.
Bradford Soap Works, Inc.
Labeler Code11118
FDA Application Number 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.
part333D
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-04-2019
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Sulfur?


Product Packages

NDC Code 11118-0009-1

Package Description: 85 g in 1 CARTON

Product Details

What are Sulfur Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SULFUR 5 g/100g - An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.

Sulfur Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Sulfur Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Sulfur Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



Sulfur 5%


Purpose



Acne Treatment


Indications & Usage



 For the treatment of acne. • Dries acne blemishes and allow skin to heal. • Helps prevent new acne blemishes from forming.


Warnings



For external use only.


Keep Out Of Reach Of Children



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


Stop Use



Stop use and ask a doctor if excessive skin irritation develops or increases.


Dosage & Administration



Apply soap to hands or wash cloth. • Gently was affected areas one to three times daily. • Leave on skin for several minutes, then rinse and pat dry. • If bothersome drying or peeling occurs, reduce application to once a day or every other day


Inactive Ingredients



Aloe vera leaf, alpha-bisabolol, chamomile (Matricaria recutita) flower extract, fo-ti (Polygonium multflorum) root extract, glycerin (vegetable), hawthorn (Crategus monogyna) berry extract, pentasodium pentetate, rosemary (Rosmarinus officinalis) leaf extract, sage (Salvia officinalis) aerial part extract, sodium chloride, sodium cocoate (coconut), sodium palmate, tetrasodium etidonate, water.


Dermaklear Label



3   59800 01070    3

NDC 59800-0107-0

ENZYMATIC dermaklear

THERAPY

 dermaklear®

Acne treatment soap

Deep cleansing • active sulfur

PLANT BASED • NET WT 3 OZ (85 g)

Penetrates pores to control acne blemishes, whiteheads and blackheads

No benzoyl peroxide to cause dry skin

Drug Facts

Active ingredient……Purpose

Sulfur 5%.........Acne treatment

Uses

• For the treatment of acne. • Dries acne blemishes and allow skin to heal. • Helps prevent new acne blemishes from forming.

Warnings:

For external use only.

When using this product: • do not get into eyes. • dryness or irritation of the skin may increase if other topical acne medications are used at the same time or immediately following use of this product. If this occurs, only on medication should be used unless directed by a doctor. • apply only to areas with acne.

Do not use on: • broken skin. • large areas of skin.

Stop use and ask a doctor if excessive skin irritation develops or increases.

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

Directions

• Apply soap to hands or wash cloth. • Gently was affected areas one to three times daily. • Leave on skin for several minutes, then rinse and pat dry. • If bothersome drying or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

Aloe vera leaf, alpha-bisabolol, chamomile (Matricaria recutita) flower extract, fo-ti (Polygonium multflorum) root extract, glycerin (vegetable), hawthorn (Crategus monogyna) berry extract, pentasodium pentetate, rosemary (Rosmarinus officinalis) leaf extract, sage (Salvia officinalis) aerial part extract, sodium chloride, sodium cocoate (coconut), sodium palmate, tetrasodium etidonate, water.

©2015 Distributed by Enzymatic Therapy Brands, LLC (part of Nature’s Way Brands, LLC), Green Bay, WI 54311 USA • Questions? 1-800-783-2286/enzy.com

dermaklear®

312428


* Please review the disclaimer below.