FlexGen by Lifetech Resources, LLC FLEXGEN- menthol cream

FlexGen by

Drug Labeling and Warnings

FlexGen by is a Otc medication manufactured, distributed, or labeled by Lifetech Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

FLEXGEN 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65643-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	12.5 mg  in 1 g

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65643-010-02	57 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2006

Labeler - Lifetech Resources, LLC (662559110)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		662559110	MANUFACTURE