FLEX24 PERFORMANCE- camphor, menthol patch

Flex24 Performance by

Drug Labeling and Warnings

Flex24 Performance by is a Otc medication manufactured, distributed, or labeled by Larasan Pharmaceutical Corporation, Dong-e E-jiao E-hua Medical Equipment Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Pregnancy or breast feeding

ask healthcare professional about use

Keep out of reach of children

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

Directions

Adults and children over the age of 12:

Remove plastic backing from patch and discard

Apply one patch to affected area

Patch should be comfortable but not tight

Repeat if necessary but no more than 3 per 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, Silicone, 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/performancepatch

SPL UNCLASSIFIED SECTION

Flex24™ Performance Patch

Quick Relief for the Pain Of

Arthritis Strains Cramps Bruises

Distributed By

Distributed by:

Larasan Pharmaceutical Corporation

401 East Las Olas Blvd., Suite 1400

Ft. Lauderdale, FL 33301

Tel. 1-855-LARASAN

NDC: 54641-006-01

Made in China

Patch size 8 cm x 13 cm

PRINCIPAL DISPLAY PANEL

Flex24™ Performance Patch
24/7 Topical Analgesic
Improve Performance
Reduce Pain
7 Large Patches
Lasts Up to 24 Hours

INGREDIENTS AND APPEARANCE

FLEX24 PERFORMANCE 
camphor, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54641-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.52 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)
BORNEOL (UNII: M89NIB437X)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
GINGER (UNII: C5529G5JPQ)
KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI)
ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)
Lemon (UNII: 24RS0A988O)
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)
MINERAL OIL (UNII: T5L8T28FGP)
MOSCHUS BEREZOVSKII MUSK SAC RESIN (UNII: Z70MFY52S4)
PETROLATUM (UNII: 4T6H12BN9U)
ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X)
ROSIN (UNII: 88S87KL877)
STAR ANISE (UNII: XKC1657P78)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54641-006-01	7 in 1 PACKAGE	04/08/2014
1		1.56 g in 1 PATCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/08/2014

Labeler - Larasan Pharmaceutical Corporation (078350375)

Establishment
Name	Address	ID/FEI	Business Operations
Dong E E Hua Medical Technology Co Ltd		527813247	manufacture(54641-006)