FLEX24 PERFORMANCE PEN- camphor (natural) and menthol liquid 
Larasan Pharmaceutical Corporation

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.

----------

Active Ingredients

Camphor, 3%

Menthol, 2.52%

Purpose

Topical analgesic

Uses

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

Warnings

For external use only

Do not

apply to open wounds, or damaged, broken, or irritated skin

Stop use and ask a doctor

if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days

Caution

  • Discontinue use if excessive irritation of the skin develops
  • Avoid contact with the eyes and mucous membranes
  • Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately

Pregnant or breast feeding

ask healthcare professional about use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children over the age of 12:

  • Remove plastic top from device and put aside till after treatment
  • Apply ointment to affected area
  • Repeat if necessary but no more than 3 treatments a day.

Children under 12, consult a doctor before use.

Inactive Ingredients

Angelica Dahurica Root, Atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate, Ginger, Kaempferia Galanga Root, Kusnezoff Monkshood Root (raw), Lemon, Ligusticum Sinense/Subsp. Chuanxiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Rosin, Silicon, Star Anise, Wintergreen Oil, Zinc Oxide

Other Information

Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

Questions/Comments?

www.larasan.com/performancepen

Distributed By:

Larasan Pharmaceutical Corporation

401 East Las Olas Blvd., Suite 1400

Ft. Lauderdale, FL 33301

Tel. 1-855-LARASAN

NDC 54641-004-02

Made in China

Flex24™ Performance Pen

Topical Analgesic

Aches Pains Bruises Sprains

0.34 fl. oz. (10 mL)

20140408 Flex24 Perf Pen

FLEX24 PERFORMANCE PEN 
camphor, menthol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54641-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)3 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL2.52 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANGELICA DAHURICA ROOT 
ATRACTYLODES LANCEA ROOT 
BORNEOL 
ANGELICA SINENSIS ROOT 
CHONDROITIN SULFATE (BOVINE) 
GINGER 
KAEMPFERIA GALANGA ROOT 
ACONITUM KUSNEZOFFII ROOT 
LEMON 
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT 
MINERAL OIL 
MOSCHUS BEREZOVSKII MUSK SAC RESIN 
ACONITUM NAPELLUS ROOT 
PETROLATUM 
ROSIN 
SILICON 
STAR ANISE 
METHYL SALICYLATE 
ZINC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54641-004-0210 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/08/2014
Labeler - Larasan Pharmaceutical Corporation (078350375)
Establishment
NameAddressID/FEIBusiness Operations
Dong-e E-jiao E-hua Medical Equipment Co Ltd527813247manufacture(54641-004)

Revised: 4/2014
Document Id: c6342474-9b78-4ca9-b0e6-92db0d3c7d56
Set id: 83e34c16-d505-4d6b-af22-cf21ed6da109
Version: 2
Effective Time: 20140409
 
Larasan Pharmaceutical Corporation