NDC 11118-0009 Sulfur

Sulfur

NDC Product Code 11118-0009

NDC Product Information

Sulfur with NDC 11118-0009 is a a human over the counter drug product labeled by Bradford Soap Works, Inc.. The generic name of Sulfur is sulfur. The product's dosage form is soap and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 313151.

Dosage Form: Soap - 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.

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.

Sulfur 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
  • CHAMOMILE (UNII: FGL3685T2X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36)
  • PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
  • ROSEMARY (UNII: IJ67X351P9)
  • SAGE (UNII: 065C5D077J)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM COCOATE (UNII: R1TQH25F4I)
  • SODIUM PALMATE (UNII: S0A6004K3Z)
  • DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
  • WATER (UNII: 059QF0KO0R)

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: Bradford Soap Works, Inc.
Labeler Code: 11118
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: 01-04-2019 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".

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Sulfur Product Label Images

Sulfur 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

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    3NDC 59800-0107-0ENZYMATIC dermaklearTHERAPY™ dermaklear®Acne treatment soapDeep cleansing • active sulfurPLANT BASED • NET WT 3 OZ (85 g)Penetrates pores to control acne blemishes, whiteheads and blackheadsNo benzoyl peroxide to cause dry skinDrug FactsActive ingredient……PurposeSulfur 5%.........Acne treatmentUses• 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 ingredientsAloe 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.comdermaklear®312428

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