Dosage and administration
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.
FlexGën ™ Topical Analgesic Pain Relief Cream
- Manufacturer
- Lifetech Resources, LLC
- Effective date
- 2010-05-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:53:08
Label at a glance#
ProductFlexGen
Active ingredientMenthol
Label structure11 sections
Storage and handling
Store in a cool, dry place.
Contacts and useful links#
Websitewww.newvitality.com
www.NewVitality.com
www.NewVitality.comLabel contents#
Full prescribing information#
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
OTC - WHEN USING SECTION
- 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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- 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 11735www.NewVitality.com
PRINCIPAL DISPLAY PANEL - 57 grams Jar Label
New Vitality™
FlexGën™
Topical Analgesic Pain Relief Cream
2 oz. (57 grams)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65643-010-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d890-621f-e053-dbdaa90a74ad | FlexGën ™ Topical Analgesic Pain Relief Cream |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Menthol | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| Menthol | ACTIVE MOIETY | L7T10EIP3A | 1 |
Products#
Every source-derived product name is available through these pages.
- FlexGen
- Menthol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65643-010 | 65643-010-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Menthol | L7T10EIP3A | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| af1e5df5-7d6d-4052-b2c5-61f9507ec50e | 265c283e-6386-4ed4-a171-c3c5a6198b18 | 2010-05-26 | Warnings | af1e5df5-7d6d-4052-b2c5-61f9507ec50e 265c283e-6386-4ed4-a171-c3c5a6198b18 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.