JOINTFLEX- camphor cream

JOINTFLEX by

Drug Labeling and Warnings

JOINTFLEX by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, SmartScience Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Strides Pharma Inc.

East Brunswick, NJ 08816

www.jointflex.com

PRINCIPAL DISPLAY PANEL - 114 g Tube Carton

Immediate and
Long Term Improving
Pain Relief1

Joint
Flex®
Out™
Pain

Arthritis
Pain
Relief
Cream

Penetrates
Deeply

Relieves back,
knee, neck
and shoulder pain

with Glucosamine
& Chondroitin
Sulfate for Skin
Conditioning

NET WT
4 OZ (114g)

EXCLUSIVE
FUSOME®
SKIN DELIVERY SYSTEM

INGREDIENTS AND APPEARANCE

JOINTFLEX 
camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-813
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.58 g  in 114 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ACETYLATED LANOLIN (UNII: 2X654GD19H)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYLATED LANOLIN (UNII: EOI0B9800C)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
PANTHENOL (UNII: WV9CM0O67Z)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SHARK CARTILAGE (UNII: D2YCN1I522)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-813-45	1 in 1 CARTON	04/16/2010
1		114 g in 1 TUBE; 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	part348	04/16/2010

Labeler - Strides Pharma Inc (078868278)

Establishment
Name	Address	ID/FEI	Business Operations
SmartScience Laboratories Inc		035907919	manufacture(59556-813) , pack(59556-813)