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Power Relief

Dosage form: gel
Ingredients: Menthol 2mL in 100mL
Labeler: Clientele, Inc.
NDC Code: 64483-007

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.

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

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings
  • For external use only.

  • 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
  • Adults and children 2 years of age and older:
    apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age, consult a Physician.

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

POWER RELIEF 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64483-007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Camphor (Synthetic)0.52 mL  in 100 mL
Water84.61 mL  in 100 mL
Eucalyptus oil0.81 mL  in 100 mL
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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: 09/2011
 
Clientele, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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