JointFlex® - OUT PAIN™ Arthritis Pain Relief Cream Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

JOINTFLEX - camphor cream 
MOBERG PHARMA NORTH AMERICA LLC

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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JointFlex® - OUT PAIN™
Arthritis Pain Relief Cream

Drug Facts

Active Ingredients

Camphor (3.1%)

Purpose

Counterirritant

Uses

Temporarily relieves minor pain associated with:

  • minor arthritis pain 
  • simple backache
  • muscle sprains and strains
  • simple backache
  • bruises 
  • cramps

Warnings

For external use only

Do not use if

  • skin is irritated or damaged
  • excessive irritation develops
  • 12 years of age or under

When using this product

  • use only as directed

  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • do not bandage tightly or use a heating pad
  • do not swallow. If swallowed, contact a physician or contact a poison control center immediately

Stop use and ask doctor if

  • condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness develops

If pregnant or breast feeding,

ask a health professional before use

Keep out of reach of children.

Directions

  • cleanse, rinse and dry skin prior to application
  • apply generously to painful muscles and joints, gently massaging until the JointFlex Pain Relieving Cream disappears.
  • repeat as necessary but no more than 4 times a day
  • for optimum benefit, use daily for at least two weeks and continue to use daily thereafter.

Other

  • store at room temperature with the cap closed
  • notice: Because this product contains natural nutrients, color may vary

Inactive Ingredients

Acetylated Lanolin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera, C12-15 Alkyl Benzoate, Chondroitin Sulfate, Diazolidinyl Urea, Dimethicone, Dimethiconol Stearate, Disodium EDTA, dl Panthenol, Glucosamine Sulfate, Glycerin, Glycerol Stearate, Glycosaminoglycans, Hydroxylated Lanolin, Hydroxpropylene Methycellulose, Idopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Tocopheryl Acetate (Vitamin E).

Questions or comments?

Call toll free 1-888-464-3336.

Moberg Pharma North America LLC

7 East Frederick Place, Suite 100
Cedar Knolls, NJ 07927

www.jointflex.com

Principal Display Panel

New Look!
Same Trusted Formula

Immediate and Long Term Improving Pain Relief1

JointFlex®- OUT PAIN™
Arthritis Pain Relieving Cream

Penetrates Deeply

Relieves back, knee, neck and shoulder pain
with Glucosamine & Chondroitin Sulfate for Skin Conditioning

EXCLUSIVE FUSOME® SKIN DELIVERY SYSTEM

NET WT 4 OZ (114g)

JointFlex® GUARANTEE
"If you use JointFlex as directed and are not completely amazed with the pain relief you received, simply return the tube (even if it's empty) and the cash register receipt to the address below for a full refund. No questions asked."

Questions or comments?
Call toll free 1-888-464-3336.

Moberg Pharma North America LLC
7 East Frederick Place, Suite 100
Cedar Knolls, NJ 07927
www.jointflex.com

Made in USA

FDA Drug Registration No. NDC: 16864-001-01
JointFlex, JointFlex-Out Pain are registered trademarks of Moberg Pharma North America LLC.
Fusome is a registered trademark of SmartScience Laboratories, Inc.
©2015 Dist. by Moberg Pharma North America LLC

1 With continued use. The eight-week clinical trial, published in the Journal of Rheumatology, involved 63 patients who had suffered from chronic osteoarthritis knee pain for an average of 10 years.

82-2701.01

JointFlex Pain Relieving Cream Box
JOINTFLEX 
camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 16864-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET) Camphor (synthetic)3.58 g  in 114 g
Inactive Ingredients
Ingredient NameStrength
Acetylated Lanolin (UNII: 2X654GD19H)  
Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36)  
Alkyl (c12-15) Benzoate (UNII: A9EJ3J61HQ)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
Chondroitin Sulfate (shark) (UNII: 2ZAJ1K50XH)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Dimethicone (UNII: 92RU3N3Y1O)  
Polyoxyl 40 Stearate (UNII: 13A4J4NH9I)  
Edetate Disodium (UNII: 7FLD91C86K)  
Panthenol (UNII: WV9CM0O67Z)  
Glucosamine Sulfate Potassium Chloride (UNII: 15VQ11I66N)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Shark Cartilage (UNII: D2YCN1I522)  
Hydroxylated Lanolin (UNII: EOI0B9800C)  
Hypromelloses (UNII: 3NXW29V3WO)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
Methyl Gluceth-20 (UNII: J3QD0LD11P)  
Methyl Glucose Sesquistearate (UNII: V1YW10H14D)  
Peppermint Oil (UNII: AV092KU4JH)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
.alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 16864-001-011 in 1 CARTON04/16/201008/31/2019
1114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/16/201008/31/2019
Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)
Establishment
NameAddressID/FEIBusiness Operations
SmartScience Laboratories, Inc.035907919manufacture(16864-001)

Revised: 9/2018