P3 AI by CONTRAD SWISS / SIPRES SRL P3 AI gel

P3 AI by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Glycerine

Hydrolyzed Soy Protein

Purpose

Skin Protectant

Uses

Pre and post regenerative skin protectant topical

Pain reliever aid. Eases discomfort associated with inflammation 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.

Warnings

For External Use Only

Do not use other creams or cosmetics with the monodose.

Do not get the area wer once the patch is in place.

Avoid Contact with Eyes

Stop Use and Ask the 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.

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

Package. Label Principal Display Panel

INGREDIENTS AND APPEARANCE

P3 AI 
p3 ai gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72582-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10 g  in 100 g
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) (HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) - UNII:1394NXB9L6)	HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)	0.12 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72582-001-01	1 in 1 CARTON	03/31/2019
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	03/31/2019

Labeler - CONTRAD SWISS (486203529)

Registrant - CONTRAD SWISS (486203529)

Establishment
Name	Address	ID/FEI	Business Operations
SIPRES SRL		440712842	manufacture(72582-001)

Establishment
Name	Address	ID/FEI	Business Operations
CONTRAD SWISS		486203529	label(72582-001)