NDC 49825-128 Amino Mask Bioelements

Sulfur

NDC Product Code 49825-128

NDC 49825-128-02

Package Description: 1 JAR in 1 BOX > 73 mL in 1 JAR (49825-128-01)

NDC 49825-128-04

Package Description: 1 JAR in 1 BOX > 118 mL in 1 JAR (49825-128-03)

NDC Product Information

Amino Mask Bioelements with NDC 49825-128 is a a human over the counter drug product labeled by Bioelements. The generic name of Amino Mask Bioelements is sulfur. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bioelements

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.

Amino Mask Bioelements 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 5 g/100mL

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)
  • KAOLIN (UNII: 24H4NWX5CO)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • BENTONITE (UNII: A3N5ZCN45C)
  • CHONDRUS CRISPUS (UNII: OQS23HUA1X)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • WINE GRAPE (UNII: 3GOV20705G)
  • KIWI FRUIT (UNII: 71ES77LGJC)
  • HONEY (UNII: Y9H1V576FH)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • BIOTIN (UNII: 6SO6U10H04)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • ALLANTOIN (UNII: 344S277G0Z)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Bioelements
Labeler Code: 49825
FDA Application Number: part358H 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: 06-14-2013 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.

Amino Mask Bioelements 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          PurposeSulfur 5%                   Acne treatment

Otc - Purpose

UseFor the treatment of acne

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

When using this product: skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs only use one topical acne medication at a time. Apply only to areas with acne.

Warnings

WarningsFor external use onlyDo not use on: Broken skin, large areas of the skin. Stop use and and ask a doctor: if irritation occurs or gets worse. Do not get into eyes.

Dosage & Administration

DirectionsCleanse the Skin thoroughly before applying this product. Cover the entire affected area with a thin layer and let dry 15 minutes then rinse well. Use twice a week. Because excessive drying of the skin may occur, start with one application, then gradually increase to two times a week if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application or discontinue use.

Inactive Ingredient

Inactive ingredientsWater (Aqua) (Eau), Kaolin, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Ceteareth-20, Glyceryl Stearate, PEG-100 Stearate, Dipotassium Glycyrrhizate, Lactic Acid, Bentonite, Chondrus Crispus (Carrageenan), Titanium Dioxide (CI 77891), Lavendula Angustifolia (Lavender) Oil, Camellia Sinensis (Green Tea) Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Actinidia Chinensis (Kiwi) Extract, Mel (Honey) Extract (Miel Extrait de Mile), Niacinamide, Biotin, Panthenol, Allantoin, Pyroxidine HCL, Hydrolyzed Soy Protein, Phenoxyethanol, Ethylhexylglycerin.

* Please review the disclaimer below.