FDA.reportPublic FDA data

P3 OA

Manufacturer
SIPRES SRL | CONTRAD SWISS SA
Effective date
2021-11-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:28:58

Label at a glance#

ProductP3 OA
Active ingredientSACCHAROMYCES CEREVISIAE, GLYCERIN
Label structure9 sections

Indications and uses

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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Saccharomyces Cerevisiae

Glycerin

Purpose

OTC - PURPOSE SECTION

Pre and post regenerative skin protectant topical

For the temporary relief of moderate aches and pains of muscles and joints associated with Osteoarthritis

Uses

INDICATIONS & USAGE SECTION

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.

Warnings

WARNINGS SECTION

For External Use Only

WARNINGS AND PRECAUTIONS SECTION

For External Use Only

WARNINGS AND PRECAUTIONS SECTION

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

WARNINGS AND PRECAUTIONS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Stop use and ask doctor if

OTC - STOP USE SECTION

Condition Worsens
Symptoms last more than 7 days

Directions

DOSAGE & ADMINISTRATION SECTION

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

ACCESSORIES

Store at room temperature 20-25◦C (68-77◦F) in a dry place, out of direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

@ info@contrad.ch

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackSecondary Pack

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52371-01052371-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHAROMYCES CEREVISIAE978D8U419HACTIB
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER788QAG3W8AIACT
CARBOMER 934Z135WT9208IACT
PEG-40 CASTOR OIL4ERD2076EFIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZOIC ACID8SKN0B0MIMIACT
GLYCERINPDC6A3C0OXACTIB
MAGNESIUM DISODIUM EDTANDT563S5VZIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e4625695-492a-db10-e053-2a95a90a4c83d047af48-d29d-8792-e053-2995a90ad6572022-07-22WarningsExact identifier
spl set id: d047af48-d29d-8792-e053-2995a90ad657

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.