P3 RG: Package Insert and Label Information

P3 RG- glycerin and pork collagen 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.

Glycerin

Pork Collagen

Purpose

Skin Protectant

External Analgesic

Uses

Pre and post regenerative skin protectant topical

For the temporary relief of aches and pains of muscles and joints associated with backache, knee pain, connective tissue inflammation, strains and stiffness.

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 20-25◦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

PRINCIPAL DISPLAY PANEL

P3 RG PACKAGING
(click image for full-size original)

P3 RG
p3 rg gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72582-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 10 g in 100 g
PORK COLLAGEN (PORK COLLAGEN) PORK COLLAGEN 0.19 g in 100 g
Inactive Ingredients
Ingredient Name Strength
DISODIUM LAURETH SULFOSUCCINATE
XANTHAN GUM
CARBOMER 934
DEHYDROACETIC ACID
MAGNESIUM DISODIUM EDTA
ETHYLHEXYLGLYCERIN
PANTHENOL
PEG-40 CASTOR OIL
PHENOXYETHANOL
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER
PROPYLENE GLYCOL
SODIUM HYDROXIDE
WATER
BENZOIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72582-003-01 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 (72582-003-01) 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 (72582-003-01)
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 (72582-003)
Establishment
Name Address ID/FEI Operations
CONTRAD SWISS 486203529 label (72582-003)

Revised: 11/2019 CONTRAD SWISS

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