Prosacea

Sulphur


Denison Pharmaceuticals Inc.
Human Otc Drug
NDC 0295-7300
Prosacea also known as Sulphur is a human otc drug labeled by 'Denison Pharmaceuticals Inc.'. National Drug Code (NDC) number for Prosacea is 0295-7300. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Prosacea drug includes Sulfur - 1 [hp_X]/g . The currest status of Prosacea drug is Active.

Drug Information:

Drug NDC: 0295-7300
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Prosacea
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Sulphur
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Denison Pharmaceuticals Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:SULFUR - 1 [hp_X]/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 18 Jan, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Denison Pharmaceuticals Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0072959080211
UPC stands for Universal Product Code.
UNII:70FD1KFU70
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0295-7300-041 TUBE in 1 CARTON (0295-7300-04) / 21.25 g in 1 TUBE18 Jan, 2019N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose rosacea/acne treatment

Product Elements:

Prosacea sulphur aloe vera leaf trolamine water diazolidinyl urea edetate sodium methylparaben propylparaben carbomer copolymer type a lactose propylene glycol sulfur sulfur

Indications and Usage:

Uses for the treatment of rosacea, redness, acne and other eruptions of the skin.

Warnings:

Warnings for external use only

Do Not Use:

Warnings for external use only

When Using:

When using this product avoid contact with the eyes apply only to areas with rosacea skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. if irritation occurs, use only one topical acne medication at a time.

Dosage and Administration:

Directions read all package directions and warnings before use. use only as directed. clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer of prosacea gel one to three times daily. massage gently until absorbed into the skin. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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. intended for use by normally healthy adults only. persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor. sensitivity test for a new user. apply product sparingly to one or two small affected areas during the first 3 days. if no discomfort occurs, follow the directions stated above.

Stop Use:

Stop use and ask a doctor if skin irritation occurs or gets worse.

Information for Patients:

Other information you may report serious side effects to the phone number provided under questions? below.

Spl Patient Package Insert:

Dermatologist recommended prosacea ® medicated rosacea gel heal, don't conceal tm , your rosacea symptoms control rosacea symptoms: redness, pimples, irritation and see visible results in just days what is rosacea? rosacea is a condition that is characterized by persistent redness and inflammation of the skin on the cheeks, nose, chin or forehead. rosacea is generally thought to affect those with fair skin, though it can affect all skin types. symptoms may also include acne-like bumps and visible blood vessels. rosacea is commonly known to be aggravated by anything that causes a flushing reaction (increased blood flow) in the skin, including alcohol consumption, exposure to sun or extreme temperatures, spicy foods or other irritants. rosacea symptoms do not typically disappear if left untreated and in some cases can worsen. symptoms may vary among sufferers, with intermittent episodes of symptom improvement and worsening over time. generally, rosacea progresses through three symptom
atic stages: stage 1: in the earliest stage of rosacea, the most common symptoms can include subtle to moderate redness, stinging, burning, dryness or tightness of skin. tiny visible blood vessels (telangiectasia) may also appear on the skin's surface. skin may begin to react to certain cosmetics, and may also be more reactive to temperature changes or become sensitive to certain foods. stage 2: as the condition progresses, redness becomes more persistent. larger areas of the face may become affected. the formation of papules (red bumps) or pustules (resembling pimples) and swelling may develop. facial pores and sebaceous follicles may become larger and more prominent. stage 3: generally, stage-3 rosacea is less common, but individuals diagnosed with this advanced stage of rosacea exhibit all characteristics of stages 1 and 2. facial features may become thicker, irregular or even exhibit gradual deformation. affected areas of the skin become a deeper shade of red. the sebaceous glands may be extremely enlarged, contributing to further redness, inflammation, papules, pustules and swelling of facial features. if you believe you may have rosacea, do not delay in consulting a doctor for proper diagnosis and advice. suggestions for how to avoid and control flare-ups: medical experts have suggested some ways to avoid aggravating symptoms which include: avoid direct sunlight as rosacea symptoms can be triggered or worsened by exposure to sunlight. when in the sun, use a mild sunscreen. avoid rubbing or scrubbing affected areas, which can irritate the skin or stimulate increased blood flow to the areas. use mild soaps, moisturizers and sunscreens and be sure to gently apply them to the face in order to avoid irritating affected areas. avoid hot drinks, spicy foods and alcoholic beverages that can cause flushing. protect your skin from extreme hot and cold conditions. avoid cosmetics, soaps, and other facial products that contain ingredients such as alcohol, menthol and fragrances. keep a log of any products, medicines, foods or weather and/or environmental conditions that may trigger flushing episodes or symptom flare-ups in order to avoid them in the future. consult your doctor for treatment recommendations. some additional suggestions for overall good skin health: get adequate rest avoid emotional stress where possible avoid excessive/stressful exercise which might cause skin flushing drink adequate amounts of water daily keep hands and face clean shampoo hair regularly using a mild antibacterial shampoo avoid touching affected areas use a broad-spectrum, spf 25+ sunscreen and mild moisturizer daily how prosacea ® gel can help prosacea contains sulphur 1x, a medically recognized homeopathic ingredient that has been recognized for relief of common rosacea symptoms such as redness, bumps and irritation, when used as directed. prosacea 's non-oily formula is non-comedogenic (doesn't cause pimples) and won't clog pores. it is important for successful results that once treatment is started with prosacea , it is continued uninterrupted, carefully following and adhering to package directions until satisfactory results are achieved or given further advice from a doctor. for best results: after applying prosacea gel to your face, let it absorb fully into your skin before applying your moisturizer or sunscreen. www.prosacea.com no gluten ingredients

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Further Questions:

Questions? 1-800-792-2582


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* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.