INTEGRATIVE THERAPEUTICS, INC. JOINT GEL - levomenthol gel 
Northwest Cosmetic Labs

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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JointGel Label

Premier Science

Integrative Therapeutics Inc.

NF Formulas



JOINT GEL

Topical Analgesic Roll-On

I-Menthol 1.25%

Fast-Acting relief from arthritis, backache, joint and muscle pain

1.7  FL OZ (49.4 mL)

Active Ingredient                                        Purpose

I-Menthol 1.25% (from peppermint oil)                        Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, sprains and strains.

Warnings

For external use only.  Avoid contact with eyes and mucus membranes.  Do not use on open wounds, damaged or irritated skin.  Do not bandage tightly.  A transient burning sensation may occur upon initial application, but usually disappears in a few days.  If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again, with in a few days, discontinue use and consult a health professional.  Do not use if shrink sleeve is broken or missing.  Do not use if adverse effects occur.

FLAMMABLE: Keep away from heat or flame.

If you are pregnant or breast feeding,consult with a health professional prior to use.  If swallowed, get medical assistance or contact a Poison Control Center Immediately.   KEEP OUT OF REACH OF CHILDREN.

Directions:

For adult and children over 12 years of age.  Shake well before use.  Roll on to affected area not more than 3 to 4 times daily.  For best results, massage into skin until absorbed.  Wash handsafter use.  If applying to hands, wait 30 minutes before washing.  For optimum relief, apply every day, up to 3 to 4 times daily.  For children under the age of 12, consult a health professional.


Inactive Ingredients Aloe leaf juice, eucalyptus leaf oil, ginger root oil, glycerin, C13-14 isoparaffin, laureth-7, methylsulfonlmethane (MSM), peppermint leaf oil, pine bark extract, polyacrylamide, rosemary leaf oil, SD alcohol 40-B, water, white willow bark extract

Topical Analgesic roll-on, cool mint scent, camphor-free, greaseless easy-to-use roll-on gel that provides fast-acting temporary relief from arthritis, backache, as well as minor joint and muscle pain.

Distributed by an FDA-Registered drug Establishment for Integrative Therapeutics, Inc.  Green Bay, WI 54311  USA

www.integrativeinc.com   1.800.931.1709

INTEGRATIVE THERAPEUTICS, INC. JOINT GEL 
levomenthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62282-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOMENTHOL (UNII: BZ1R15MTK7) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
PINUS STROBUS (UNII: K39FUU78ES)  
ALCOHOL (UNII: 3K9958V90M)  
ROSEMARY (UNII: IJ67X351P9)  
GINGER (UNII: C5529G5JPQ)  
WHITE WILLOW EXTRACT (UNII: 205MXS71H7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62282-052-0149.4 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34808/01/2002
Labeler - Northwest Cosmetic Labs (929572014)

Revised: 11/2009
 
Northwest Cosmetic Labs