FLEX24 PAIN PEN- camphor liquid

FLEX24 PAIN PEN by

Drug Labeling and Warnings

FLEX24 PAIN PEN by is a Otc medication manufactured, distributed, or labeled by FLEX24, INC., Dong E E Hua Medical Technology Co, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Camphor, 7.79%

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscle and joints associated with simple 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 immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children 2 years of age and older:

Remove plastic top from device and put aside till after treatment

Squeeze device if necessary and apply ointment to the affected area

Repeat as necessary but no more than 3 treatments per day

Children under 2 years of age, consult a physician.

Inactive Ingredients

Aconitum Kusnezoffii Root, Angelica Dahurica Root, Angelica Sinesis Root, Asarum Heterotropoides var. Drynaria Fortunei Root, Eleutherococcus Nodiflorus Root Bark, Ethyl Alcohol, Eucalyptus Oil, Frosythia Suspensa Fruit, Frankincense, Gardenia Jasminoides Fruit, Lavender Oil, Lemon, Myrrh, Paeonia Suffruticosa Root Bark, Peppermint Oil, Pinellia Ternata Root, Red Paeonia Lactiflora Root, Rehmannia Glutinosa Root (Raw), Rhubarb, Safflower, Tangerine Peel, Turmeric, White Paeonia Lactiflora Root, Wintergreen Oil, Zanthoxylum Nitidum Root, Zeodary

SPL UNCLASSIFIED SECTION

FLEX24®

RECOVER NATURALLY

Dist: FLEX24, INC.

        4020 Galt Ocean Mile, Ste. 1607

        Ft. Lauderdale, FL 33308

        Tel.: 844.4.FLEX24

Formulated in USA

Made in China

PRINCIPAL DISPLAY PANEL

ROLL-ON PEN

PAIN RELIEF

WORKS FOR ARTHRITIS

ALL NATURAL

FAST ACTING

LONG LASTING

Topical Analgesic

0.61 fl. oz. (18 mL)

Plant based medicine for pain relief

Fast acting and long lasting

Works for: aches, pains, & strains

FLEX24®

RECOVER NATURALLY

INGREDIENTS AND APPEARANCE

FLEX24 PAIN PEN 
camphor liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73218-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	7.79 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)
ALCOHOL (UNII: 3K9958V90M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)
FRANKINCENSE (UNII: R9XLF1R1WM)
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LEMON (UNII: 24RS0A988O)
MYRRH (UNII: JC71GJ1F3L)
PAEONIA SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)
PEPPERMINT OIL (UNII: AV092KU4JH)
PINELLIA TERNATA ROOT (UNII: G9AET085M5)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
RHUBARB (UNII: G280W4MW6E)
SAFFLOWER (UNII: 4VBL71TY4Y)
TANGERINE PEEL (UNII: JU3D414057)
TURMERIC (UNII: 856YO1Z64F)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)
ZEDOARY (UNII: 123C43G128)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73218-003-01	18 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/28/2019

Labeler - FLEX24, INC. (117114024)

Establishment
Name	Address	ID/FEI	Business Operations
Dong E E Hua Medical Technology Co, Ltd		527813247	manufacture(73218-003)