FlexGen

Dosage form: cream
Ingredients: Menthol 12.5mg in 1g
Labeler: Lifetech Resources, LLC
NDC Code: 65643-010

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.

FlexGën
Topical Analgesic Pain Relief Cream

Drug Facts

Active Ingredients

Menthol (1.25%)

Purpose

Topical Analgesic

Use

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

Warnings
  • For external use only

  • Avoid contact with eyes
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days, discontinue use of product and consult a physician.
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly

  • Keep out of the reach of children
  • If swallowed, get medical help or contact a poison control center right away.

Directions

Adults and children 2 yrs. of age and older. Apply to affected area not more than 3 to 4 times per day. Children under 2 yrs. of age: consult a physician.

Inactive Ingredients

Benzyl Alcohol, Butylparaben, Carbomer, Proprietary Blend of Fatty Acid Esters, Ethylparaben, Glycerin, Glyceryl Stearate, Isobutylparaben, Lecithin, Methylparaben, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Peppermint Oil, Phenoxyethanol, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Water.

Other Information

Store in a cool, dry place.

Questions?

800-943-6465

FlexGën Cream

New Vitality
260 Smith Street
Farmingdale, NY 11735
www.NewVitality.com

PRINCIPAL DISPLAY PANEL - 57 grams Jar Label

New Vitality

FlexGën

Topical Analgesic Pain Relief Cream

2 oz. (57 grams)

FLEXGEN 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65643-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol12.5 mg  in 1 g
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65643-010-0257 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2006
Labeler - Lifetech Resources, LLC (662559110)
Establishment
NameAddressID/FEIOperations
Lifetech Resources, LLC662559110MANUFACTURE

Revised: 05/2010
 
Lifetech Resources, LLC

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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