FLEX24 PAIN- camphor menthol patch

Flex24 Pain by

Drug Labeling and Warnings

Flex24 Pain by is a Otc medication manufactured, distributed, or labeled by Larasan Pharmaceutical Corporation, Dong E E Hua Medical Technology 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 backache, arthritis, strains, cramps, 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 immedately

Pregant or breast feeding

ask a 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 backing from patch and discard
• Apply one patch to affected area
• Repeat if necessary, but no more than 3 per day
• Patch shold be comfortable but not tight

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/painpatch

SPL UNCLASSIFIED SECTION

Flex24™ Pain Patch

Quick Relief for the Pain of

Arthritis Strains Cramps Bruises

Distributed by:

Larasan Pharmaceutical Corporation

401 East Las Olas Blvd., Suite 1400

Ft. Lauderdale, FL 33301

Tel. 1-855-LARASAN

NDC: 54641-005-01

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEX24 PAIN 
camphor menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54641-005
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: 54641-005-01	7 in 1 PACKAGE	09/12/2014
1		1.56 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/12/2014

Labeler - Larasan Pharmaceutical Corporation (078350375)

Establishment
Name	Address	ID/FEI	Business Operations
Dong E E Hua Medical Technology Co Ltd		527813247	manufacture(54641-005)