P3 AI by SIPRES SRL / Contrad Swiss SA

P3 AI by

Drug Labeling and Warnings

P3 AI 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 AI- p3 ai 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

Hydrolyzed Soy Protein

Glycerin

Purpose

Skin Protectant

External Analgesic

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.

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.

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 20-24-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

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

Principal Display Panel

P3 AI 
p3 ai gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52371-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52371-000-01	1 in 1 CARTON	11/07/2021
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	11/07/2021	02/28/2022

Labeler - SIPRES SRL (440712842)

Registrant - Contrad Swiss SA (486203529)

Establishment
Name	Address	ID/FEI	Business Operations
SIPRES SRL		440712842	manufacture(52371-000)

Revised: 7/2022

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

34390-5

Set id: cff52c80-cc9b-46ae-e053-2a95a90a64be

Version: 2

Effective Time: 20220722

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