NDC 73159-001 Enzoclear Foam

Benzoyl Peroxide

NDC Product Code 73159-001

NDC Product Information

Enzoclear Foam with NDC 73159-001 is a a human prescription drug product labeled by Lacer Pharma, Llc. The generic name of Enzoclear Foam is benzoyl peroxide. The product's dosage form is aerosol, foam and is administered via topical form.

Labeler Name: Lacer Pharma, Llc

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

Product Type: Human Prescription 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.

Enzoclear Foam 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.

  • BENZOYL PEROXIDE 9.8 g/g

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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYESTER-5 (TG-38) (UNII: 2L9351NW8W)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • STEARETH-10 (UNII: FD0913P475)
  • NORFLURANE (UNII: DH9E53K1Y8)

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: Lacer Pharma, Llc
Labeler Code: 73159
Marketing Category: UNAPPROVED DRUG OTHER - 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: 07-25-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Enzoclear Foam 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

Description

Each gram of Enzoclear™ Foam contains 9.8% benzoyl peroxide in an aqueous based emollient foam vehicle containing BHT, C12-15 alkyl benzoate, cetostearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, methylparaben, polyester-5, propylene glycol, propylparaben, purified water, sodium citrate, steareth-10. Also contains: Propellant HFA-134a (1,1,1,2-tetrafluoroethane).Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following structure:

Clinical Pharmacology

The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide, is believed to be responsible for its usefulness in acne. Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

Indications & Usuage

Enzoclear™ Foam is indicated for use in the topical treatment of mild to moderate acnes vulgaris.

Contraindications

Enzoclear™ Foam should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product. Discontinue use if hypersensitivity is observed.

Warnings

  • FOR EXTERNAL USE ONLY. Not for ophthalmic use. Keep out of reach of children.When using this product, skin irritation and dryness is more likely to occur if:you leave Enzoclear™ Foam on your skin longer than directedyou use another topical acne medication at the same timeIf irritation occurs:use Enzoclear™ Foam less frequentlyuse one topical acne medication at a timestop use and ask a doctor if irritation becomes severeDo not use if you:have very sensitive skinare sensitive to benzoyl peroxideWhen using this productavoid unnecessary sun exposure and use a sunscreenavoid contact with the eyes, lips, and mouthavoid contact with hair and dyed fabrics, which may be bleached by this productskin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swellingContents under pressure. Do not puncture or incinerate container. Do not expose to temperature above 120°F (49°C).

Precautions

General: If severe irritation develops, discontinue use and institute appropriate therapy.Information for patients: This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. Avoid contact with the eyes, eyelids, lips, and mucous membranes. If accidental contact occurs, rinse with water. If excessive redness or irritation develops, discontinue use and consult your physician.Carcinogenesis, Mutagenesis, Impairment of Fertility: Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.Pregnancy: Category C. Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed.Nursing Mothers: It is not known whether this drug is excreted in the human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established.

Adverse Reactions

Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

Overdosage

If excessive scaling, erythema or edema occurs, the use of this preparation should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

Dosage & Administration

  • Avoid contact with hair, fabrics or carpeting as benzoyl peroxide may cause bleaching or discolorationPrime Can Before Initial Use: Shake can well. Firmly strike bottom of can onto palm of hand 3 times. Hold can upright and direct initial spray to a non-stick surface.Until foam dispenses, DO NOT spray directly on the skin as the initial spray expel cold liquid propellant. Press down on actuator for 1-3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, repeat priming process.During Use:WASH-OFF APPLICATION: Shake can well. Holding can upright, dispense Enzoclear™ Foam into palm of hand. Cover the entire affected area with a thin layer 1 to 3 times daily, or as directed by a physician. Rub in until completely absorbed. Rinse off after 2 minutes. Wipe off any excess foam from actuator after use. LEAVE-ON APPLICATION: Shake can well. Holding can upright, dispense Enzoclear™ Foam into palm of hand and apply to the affected area once daily, or as directed by a physician. For facial acne, use a dollop the size of a marble. For acne on either the back or chest, use a dollop the size of a whole walnut. Rub in until completely absorbed. Wipe off any excess foam from actuator after use.Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or once every other day. Wash hands with soap and water after use. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

How Supplied

Enzoclear™ Foam is supplied in 100g (NDC 73159-001-01) aluminum cans.Will not dispense entire contents. Container is overfilled to guarantee at least the listed amount.Store at room temperature: 59°-77°F (15°-25°C).Protect from freezing.Store upright.Manufactured for:Lacer Pharma, LLC996 N Halstead Road, Suite DOcean Springs, MS 39564Phone: (228) 872-9607

Patient Information

  • IMPORTANT: For use on skin only (topical use). When using this product, avoid unnecessary sun exposure and use a sunscreen. Avoid contact with hair and dyed fabrics, which may be bleached by this product. When using this product, skin irritation may occur.Stop use and ask a doctor if irritation becomes severe.Read the Patient Information that comes with Enzoclear™ Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of speaking with your doctor about your medical condition or your treatment.What is Enzoclear™ Foam?Enzoclear™ Foam is a prescription medicine used on the skin (topical) to treat mild to moderate acne vulgaris.Who should not use Enzoclear™ Foam?Do not use Enzoclear™ Foam if you have very sensitive skin or are sensitive to benzoyl peroxide.What should I tell my doctor before using Enzoclear™ Foam?Before using Enzoclear™ Foam, tell your doctor about all of your medical conditions, including if you:Have any allergiesAre pregnant or are planning to become pregnant. It is not known if Enzoclear™ Foam will harm your unborn baby.Are breastfeeding or plan to breast-feed. It is not known if Enzoclear™ Foam passes into your breast milk.Tell your doctor about all the medicines and skin products you use. Other skin and topical acne products may increase the irritation of your skin when used with Enzoclear™ Foam. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.Instructions for applying Enzoclear™ FoamCAUTION: Enzoclear™ Foam may bleach hair or colored fabricPrime Can Before Initial Use: Shake can well. Firmly strike bottom of can onto palm 3 times. Hold can upright and direct initial spray to a non-skin surface. Until foam dispenses, DO NOT spray directly on the skin as the initial spray may expel cold liquid propellant. Press down on actuator for 1-3 seconds until foam begins to dispense.During Use:WASH-OFF APPLICATION: Shake can well. Holding can upright, dispense Enzoclear™ Foam into palm of hand. Cover the entire affected area with a thin layer 1 to 3 times daily, or as directed by a physician. Rub in until completely absorbed. Rinse off after 2 minutes. Wipe off any excess foam from actuator after use. LEAVE-ON APPLICATION: Shake can well. Holding can upright, dispense Enzoclear™ Foam into palm of hand and apply to the affected area once daily, or as directed by a physician. For facial acne, use a dollop the size of a marble. For acne on either the back or chest, use a dollop the size of a whole walnut. Rub in until completely absorbed. Wipe off any excess foam from actuator after use. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Wash hands with soap and water after use. If going outside, apply sunscreen after using this product. If irritation or sensitivity occurs, stop use of both products and ask a doctor.Will not dispense entire contents. Container is overfilled to guarantee dispensing at least the listed amount.What should I avoid while using Enzoclear™ Foam?Limit your time in sunlight. Avoid using tanning beds or sun lamps. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and a sunscreen with SPF 15 rating or higher. Your doctor can give you more information about why this is important.Do not wash the affected area more than 2 to 3 times a day. Washing or scrubbing your skin too often may make your acne worse.What are the possible side effects with Enzoclear™ Foam?Side effects with Enzoclear™ Foam include:Skin irritation. Skin irritation and dryness is more likely to occur if you leave Enzoclear™ Foam on your skin longer than directed or use another topical acne medication at the same time. Stop use and ask a doctor if irritation becomes severe.This is not the only possible side effect with Enzoclear™ Foam. Call your doctor for medical advice about side effects. You may report side effects to Lacer Pharma, LLC at 1-833-990-0046.How should I store Enzoclear™ Foam?Store at room temperature 59°-77°F (15°-25°C). Do not expose to temperatures above 120°F (49°C). Protect from freezing. Store upright.Keep Enzoclear™ Foam and all medicines out of the reach of children.General Information about Enzoclear™ FoamMedicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Enzoclear™ Foam for a condition for which it was not prescribed. Do not give Enzoclear™ Foam to other people, even if they have the same condition you have. This leaflet summarizes the most important information about Enzoclear™ Foam. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about Enzoclear™ Foam that is written for healthcare professionals. For more information about Enzoclear™ Foam, call 1-833-990-0046.What are the ingredients in Enzoclear™ Foam?Active Ingredient: benzoyl peroxide 9.8%Inactive Ingredient: BHT, C12-15 benzoate, cetostearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, methylparaben, polyester-5, propylene glycol, propylparaben, purified water, sodium citrate, steareth-10. Also contains: Propellant HFA-134a (1,1,1,2-tetrafluoroethane)

* Please review the disclaimer below.

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