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P3 ai - Prescription Drug Labeling

Product NDC Code 52371-000
Drug Name

P3 ai

Type Generic
Active Ingredients
Hydrolyzed soy protein (enzymatic .12 g/100g
2000 mw) 10 g/100g
Glycerin
Route TOPICAL
Dosage Form GEL
Application Number part347
Labeler Name SIPRES SRL
Packages
Package NDC Code Description
52371-000-01 1 vial, single-use in 1 carton (52371-000-01) > 1 vial, single-use in 1 vial, single-use > 1.8 g in 1 vial, single-use

Adverse reactions

Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.
To report supected adverse reactions contact 1-800-332-1088

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Hydrolyzed Soy Protein Glycerin

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Pre and post regenerative skin protectant topical Pain reliever aid. Eases discomfort associated with inflammations of joints, tendons and nerves. 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.

Purpose

Information about the drug product’s indications for use.
Purpose Skin Protectant External Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
P3 AI P3 AI MAGNESIUM DISODIUM EDTA PHENOXYETHANOL WATER XANTHAN GUM BENZOIC ACID ETHYLHEXYLGLYCERIN PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER PEG-40 CASTOR OIL PROPYLENE GLYCOL SODIUM HYDROXIDE HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) GLYCERIN GLYCERIN CARBOMER 934 PANTHENOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel Secondary Pack

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask doctor if Condition Worsens Symptoms last more than 7 days

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings 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. Avoid Contact With Eyes Stop use and ask doctor if Condition Worsens Symptoms last more than 7 days Keep out reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API

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