NDC 72582-006 P3 Oa

P3 Oa

NDC Product Code 72582-006

NDC CODE: 72582-006

Proprietary Name: P3 Oa What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: P3 Oa What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

NDC 72582-006-01

Package Description: 1 VIAL, SINGLE-USE in 1 CARTON > 1 VIAL, SINGLE-USE in 1 VIAL, SINGLE-USE > 1.8 g in 1 VIAL, SINGLE-USE

NDC Product Information

P3 Oa with NDC 72582-006 is a a human over the counter drug product labeled by Contrad Swiss Sa. The generic name of P3 Oa is p3 oa. The product's dosage form is gel and is administered via topical form.

Labeler Name: Contrad Swiss Sa

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 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.

P3 Oa 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.

  • SACCHAROMYCES CEREVISIAE .89 g/100g
  • GLYCERIN 10 g/100g

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.

  • MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CARBOMER 934 (UNII: Z135WT9208)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PEG-40 CASTOR OIL (UNII: 4ERD2076EF)

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.
  • 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: Contrad Swiss Sa
Labeler Code: 72582
FDA Application Number: part347 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 10-20-2019 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.

P3 Oa 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 Ingredients

GlycerinSaccharomyces Cerevisiae

Purpose

Skin ProtectantExternal Analgesic

Uses

Pre and post regenerative skin protectant topical.For the temporary relief of moderate aches and pains of muscles and joints associated with Osteoarthritis.

Apply the monodose gel on a patch gauze to clean dry skin.
Place the patch on the affected area. Wear the patch for 4-8 hours

For External Use Only

Do not use other creams or cosmetics with the monodose.Do not get the area wet once the patch is in place.

Keep Out Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use And Ask Doctor If

Condition worsensSymptoms last more than 7 days

Directions

Apply as needed.

• Children under 6 months: ask a doctor

Apply the monodose gel on a patch gauze to clean dry skin.
Place the patch on the affected area.Wear the patch for 4-8 hours

Other Information

Store at room temperature 20-25°C (68-77°F)

in a dry place, out of direct sunlight.

Inactive Ingredients

Aqua, Benzoic acid, Carbomer,

Dehydroacetic acid, Disodium EDTA,

Ethylhexylglycerin, Panthenol, PEG-40

hydrogenated castor oil, Phenoxyethanol,

Propylene glycol, Sodium hyaluronate,

Sodium hydroxide, Xanthan gum.

Questions?

Info@contrad.ch

Adverse Reactions

To report suspected adverse reactions

contact 1-800-332-1088

* Please review the disclaimer below.