NDC 54111-116 Dr Dennis Gross Correct And Perfect

Sulfur

NDC Product Code 54111-116

NDC 54111-116-50

Package Description: 15 mL in 1 TUBE

NDC Product Information

Dr Dennis Gross Correct And Perfect with NDC 54111-116 is a a human over the counter drug product labeled by Bentley Laboratories, Llc. The generic name of Dr Dennis Gross Correct And Perfect is sulfur. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bentley Laboratories, Llc

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.

Dr Dennis Gross Correct And Perfect 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.

  • SULFUR .4875 g/15mL

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.

  • WATER (UNII: 059QF0KO0R)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • KAOLIN (UNII: 24H4NWX5CO)
  • BENTONITE (UNII: A3N5ZCN45C)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • QUERCETIN CAPRYLATE (UNII: 3U3074427O)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • FARNESOL (UNII: EB41QIU6JL)
  • EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
  • SQUALANE (UNII: GW89575KF9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • FYTIC ACID (UNII: 7IGF0S7R8I)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • TROPOLONE (UNII: 7L6DL16P1T)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM GLUCONATE (UNII: R6Q3791S76)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: Bentley Laboratories, Llc
Labeler Code: 54111
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: 05-01-2010 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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Dr Dennis Gross Correct And Perfect 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

Drug Facts Active Ingredient

Colloidal Sulfur 3.25 %

Purpose

Acne Treatment

Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Uses

  • For the treatment and management of acne

Warnings

For external use only

When Using This Product

  • Using other topical acne drugs at the same time or right after 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.

Directions

  • Cleanse skin thoroughly before applyingfor use as a spot treatment, apply over the entire affected area one to three times dailybecause excessive drying of the skin may occur, start with one application daily, the gradually increase to two or three times daily if needed or as directed by a doctor.for use as a mask, apply a thin layer to affected area. Leave on for 10 minutes, then rinse. Use only once or twice a week as needed.

Inactive Ingredients

Purified Water (Aqua Purificata). Pentylene Glycol, Kaolin, Bentonite, Cetearyl Alcohol, Titamium Dioxide (CI 77891), Magnesium Aluminum Silicate, Stearyl Alcohol, Quercetin Caprylate, Bisaolol, Farnesol, Epilobium Angustifolium Flower/Leaf/Stem Extract, Camellia Sinensis Leaf Extract, Pueraria Lobata Root Extract, Squalane, Glycerin, Xanthan Gum, Caprylic/Capric Triglyceride, Phytic Acid, Caprylyl Glycol, Butylene Glycol, Tropolone, Disodium EDTA, Sodium Gluconate, 1,2-Hexanediol, Glyceryl Oleate, Propylene Glycol, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Menthol, Silica Dimethyl Silylate, Sodium Benzoate, Potassium Sorbate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Dr Dennis Gross Correct And Perfect Product Label

Dr dennis gross™SKINCARECorrect and PerfectSpot TreatmentSulfur AcneTreatment CreamTRY ME AS A MASK0.5 fl oz/15mL eDr. Dennis Gross Skincare™, LLCDist. NY, NY 10022Made in USAVEGAN PARABEN FREEEffectively flattens and clears blemishesAbsorbs excessive oilCalms inflammation and redness

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