P3 OA by SIPRES SRL / CONTRAD SWISS SA

P3 OA by

Drug Labeling and Warnings

P3 OA by is a Otc medication manufactured, distributed, or labeled by SIPRES SRL, CONTRAD SWISS SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

P3 OA- p3 oa gel 
SIPRES SRL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Saccharomyces Cerevisiae

Glycerin

Purpose

Pre and post regenerative skin protectant topical

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

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.

Warnings

For External Use Only

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

Keep out of reach of children

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

Stop use and ask doctor if

Condition Worsens
Symptoms 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

Principal Display Panel

P3 OA 
p3 oa gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52371-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H)	SACCHAROMYCES CEREVISIAE	0.089 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52371-010-01	1 in 1 CARTON	11/08/2021
1		1 in 1 VIAL, SINGLE-USE
1		1.8 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	11/08/2021	02/28/2022

Labeler - SIPRES SRL (440712842)

Registrant - CONTRAD SWISS SA (486203529)

Establishment
Name	Address	ID/FEI	Business Operations
SIPRES SRL		440712842	manufacture(52371-010)

Revised: 7/2022

Document Id: e4625695-492a-db10-e053-2a95a90a4c83

34390-5

Set id: d047af48-d29d-8792-e053-2995a90ad657

Version: 2

Effective Time: 20220722

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