NDC 0295-7300 Prosacea

Sulphur

NDC Product Code 0295-7300

NDC Product Information

Prosacea with NDC 0295-7300 is a a human over the counter drug product labeled by Denison Pharmaceuticals Inc.. The generic name of Prosacea is sulphur. The product's dosage form is gel and is administered via topical form.

Labeler Name: Denison Pharmaceuticals Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Prosacea Active Ingredient(s)

Additional informationCallout TooltipWhat 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 1 [hp_X]/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • LACTOSE (UNII: J2B2A4N98G)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

* Please review the disclaimer below.

Prosacea Product Label Images

Prosacea 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

Sulphur 1x (10%)

Purpose

Rosacea/acne treatment

Uses

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

Warnings

For external use only

Do Not Use On

  • Broken skinlarge areas of the skin

When Using This Product

  • Avoid contact with the eyesapply only to areas with rosaceaskin 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.

Otc - Stop Use

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

Otc - 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.

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.

Other Information

You may report serious side effects to the phone number provided under





Questions? below.

Inactive Ingredients

Acrylates, aloe barbadensis leaf juice, diazolidinyl urea, lactose, methylparaben, propylene glycol, propylparaben, tetrasodium EDTA, triethanolamine, water.

Otc - Questions

Questions?  1-800-792-2582

* Please review the disclaimer below.

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