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Synovium

Profoot, Inc.

Synovium® Pain Relieving Gel


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Capsicum Oleoresin 0.0625%
(Containing Capsaicin 0.025%)

Purpose

Pain Relieving

Synovium Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, wrap, hot water bottle or any heating element

When using this product

  • do not get into eyes

  • avoid contact with other mucous membranes

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away
  • ​if pregnant or nursing, ​seek the advice of a health professional before using

Directions

  • Children under 12 years of age consult a physician
  • Apply a thin layer to affected area not more than 3 to 4 times daily
  • Gently massage into the skin until fully absorbed
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Synovium Other information

  • It is recommended to test for skin sensitivity prior to use. Apply product to a small area, follow the directions and wait 24 hours. Proceed with application if no adverse reaction.
  • A burning sensation may occur upon inital application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.
  • If applying product to hands, wait 30 minutes before washing.
  • Avoid water, heat, or direct sunlight while using product.
  • If wearing contact lenses, insert prior to application and avoid touching them after applying product.
  • If eye contact occurs, flush immediately with water.

Inactive Ingredients

Water (Aqua), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Glucosamine HCl, Emu Oil, Dimethyl Sulfone, Celosia Argentea Seed Extract, Ginkgo Biloba Extract, Panax Ginseng Root Extract, Medicago Sativa (Alfalfa) Extract, Cymbopogon Schoenanthus Extract, Tocopheryl Acetate, DMDM Hydantoin, Propylene Glycol, Methylparaben, Propylparaben.

Questions or comments?

visit www.profootcare.com

PRINCIPAL DISPLAY PANEL

Synovium®

Pain Relieving Gel

With Warming Capsaicin

4 FL OZ (118mL)

SynoviumPolyBagLabel.jpgSynovium SynoviumBottleLabel.jpgSynovium

Synovium

Capsicum Oleoresin GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:29784-413
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
capsaicin CAPSAICIN 156.25 ng

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
PEG-75 LANOLIN
Aloe Vera Leaf
POLYOXYL 40 HYDROGENATED CASTOR OIL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
TROLAMINE
POLYSORBATE 20
GLUCOSAMINE HYDROCHLORIDE
EMU OIL
DIMETHYL SULFONE
CELOSIA ARGENTEA SEED
GINKGO
ASIAN GINSENG
ALFALFA
cymbopogon schoenanthus top
.ALPHA.-TOCOPHEROL ACETATE
DMDM HYDANTOIN
propylene glycol
METHYLPARABEN
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:29784-413-04 118 in 1 BOTTLE
2 NDC:29784-413-01 1 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-11-18


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