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
■ Bandage tightly

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 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

■ Peel desired length of tape and cut with serrated edge.
■ Discard plastic backing from tape                                     ■ Repeat as necessary, but no more than 3 per day
■ Apply tape to affected area.                                             ■ Tape should be comfortably tight
■ Children under 12, consult a doctor before use

Inactive Ingredients

Angelica Dahurica, Cape Jasmine Fruit, Chinese Angelica, Cotton, Eucalyptus Oil, Ethyl Alcohol, Forsythia Seed Pod,
Fortune’s Drynaria Rhizome, Frankincense, Kusnezoff Monkshood root, Lavender Oil, Manchurian Wild Ginger, Myrrh,
Paper roll, Peppermint Oil, Pinellia Tuber, Red Peony Root, Rehmannia Root (raw), Rhubarb, Safflower, Slenderstyle
Acanthopanax Bark, Tangerine Peel, Tree Peony Bark, Turmeric, Weeping Wintergreen Oil, White Peony Root,
Zanthoxylum Nitidum, Zedoary.

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.Flex24.com/performancetape

SPL UNCLASSIFIED SECTION

Larasan Pharmaceutical Corp.

1287 E. Newport Center Drive, Suite 206

Deerfield Beach, FL 33442

PRINCIPAL DISPLAY PANEL

20170117Flex24PerfTape.jpg

INGREDIENTS AND APPEARANCE

FLEX24 PERFORMANCE 
camphor menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54641-007
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)
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
COTTON FIBER (UNII: 70LDW53ROO)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ALCOHOL (UNII: 3K9958V90M)
FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)
FRANKINCENSE (UNII: R9XLF1R1WM)
ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GINGER (UNII: C5529G5JPQ)
MYRRH (UNII: JC71GJ1F3L)
PEPPERMINT OIL (UNII: AV092KU4JH)
PINELLIA TERNATA ROOT (UNII: G9AET085M5)
PAEONIA OBOVATA ROOT (UNII: 7NPF74465O)
REHMANNIA ELATA ROOT (UNII: 4PTH680I21)
RHUBARB (UNII: G280W4MW6E)
SAFFLOWER (UNII: 4VBL71TY4Y)
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)
TANGERINE PEEL (UNII: JU3D414057)
PAEONIA SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)
TURMERIC (UNII: 856YO1Z64F)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54641-007-01	1 in 1 PACKAGE	01/16/2017
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	01/16/2017

Labeler - Larasan Pharmaceutical Corporation (078350375)

Establishment
Name	Address	ID/FEI	Business Operations
Dong-e E-jiao E-hua Medical Equipment Co Ltd		527813247	manufacture(54641-007)