P3 OA by Contrad Swiss SA / SIPRES SRL P3 OA gel

P3 OA by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS

Glycerin

Saccharomyces Cerevisiae

PURPOSE

Skin Protectant

External 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

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

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 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

ADVERSE REACTIONS

To report suspected adverse reactions
contact 1-800-332-1088

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

P3 OA 
p3 oa gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72582-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H)	SACCHAROMYCES CEREVISIAE	0.89 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72582-006-01	1 in 1 CARTON	10/20/2019
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	10/20/2019

Labeler - Contrad Swiss SA (486203529)

Registrant - Contrad Swiss SA (486203529)

Establishment
Name	Address	ID/FEI	Business Operations
SIPRES SRL		440712842	manufacture(72582-006)

Establishment
Name	Address	ID/FEI	Business Operations
CONTRAD SWISS SA		486203529	label(72582-006)