P3 AI: Package Insert and Label Information

P3 AI- hydrolyzed soy protein (enzymatic; 2000 mw) and glycerin gel
CONTRAD SWISS

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.

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

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

Package. Label Principal Display Panel

P3 AI p3 ai gel

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) 0.12 g in 100 g GLYCERIN (GLYCERIN) GLYCERIN 10 g in 100 g

Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN PANTHENOL PEG-40 CASTOR OIL PHENOXYETHANOL PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER PROPYLENE GLYCOL SODIUM HYDROXIDE WATER BENZOIC ACID XANTHAN GUM CARBOMER 934 DEHYDROACETIC ACID MAGNESIUM DISODIUM EDTA

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72582-001-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE 1 1 VIAL, SINGLE-USE in 1 VIAL, SINGLE-USE This package is contained within the CARTON (72582-001-01) and contains a VIAL, SINGLE-USE 1 1.8 g in 1 VIAL, SINGLE-USE This package is contained within a VIAL, SINGLE-USE and a CARTON (72582-001-01)

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	Operations
SIPRES SRL		440712842	manufacture (72582-001)

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

Revised: 01/2021 CONTRAD SWISS