POWER RELIEF- menthol gel 
Clientele, Inc.

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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POWERRELIEF™
COOLING PAIN RELIEF ROLL ON

Drug Facts

Active Ingredients

Menthol 2%

Purpose

Topical analgesic

Indications

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

Warnings

  • Avoid contact with the eyes.

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a Physician.

  • Do not apply to wounds or damaged skin.
     
  • Do not bandage tightly.

  • Keep out reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Water, Butylene Glycol, Aloe Barbadensis Leaf Juice, Eucalyptus Globulus Leaf Oil, Methyl Salicylate, Camphor, Mentha Piperita (Peppermint) Oil, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.

Distributed exclusively by
American Herbal Products Corp.
North Bay Village, Florida

PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label

POWERRELIEF
COOLING PAIN RELIEF ROLL ON

Net wt. 2 fl.oz (59.1 ml)
MADE IN USA

Principal Display Panel - 59.1 ml Bottle Label
POWER RELIEF 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64483-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Camphor (Synthetic) (UNII: 5TJD82A1ET) 0.52 mL  in 100 mL
Water (UNII: 059QF0KO0R) 84.61 mL  in 100 mL
Eucalyptus oil (UNII: 2R04ONI662) 0.81 mL  in 100 mL
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64483-007-0259 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/02/2004
Labeler - Clientele, Inc. (085021806)

Revised: 9/2011
Document Id: 6e942baa-cce1-43cd-ab4a-dc24d39ac9e1
Set id: 1c04696b-12ea-48c0-a853-20e0f77a6f40
Version: 1
Effective Time: 20110906
 
Clientele, Inc.