FLEX24 TAPE- camphor, menthol patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Camphor, 3%, Menthol, 2.52%
Available from:
Flex24, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains if condition worsens or if there is redness or irritation in the applied area or if symptoms persis for more than 7 days or clear up and occur again within a few days
Authorization status:
OTC monograph not final
Authorization number:
73218-004-01

FLEX24 TAPE- camphor, menthol patch

Flex24, Inc.

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.

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Active Ingredients

Camphor, 3%

Menthol, 2.52%

Purpos e

Topical Analgesic

Us es

For the temporary relief of minor aches and pains of muscles and joints associated with simple

backache, 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 persis 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. If swallowed, get medical help or contact the Poison Control Center

right away.

Directions

Adults and children over the age of 12:

Remove tape from box and cut to desired length

Apply cut tape to affected area

Repeat if necessary but no more than 3 per day

Tape should be comfortable but not tight

Sensitive skin - remove tape under water

Children under 12 years of age, consult a doctor

Inactive Ingredients

Angelica Dahurica Root, atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate,

Ginger, Kaempferia Galanga Root, Kusnezoff Monkshoot Root (raw), Lemon, Ligusticum Sinese Subsp.

Chuansiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Silicone, Star Anise, Wintergreen Oil,

Zinc Oxide

RELIEF FOR:

WRIST PAIN

ELBOW STRAIN

SHOULDER PAIN

BACK PAIN

CALF STRAIN

ANKLE SPRAIN

HAMSTRING SPRAIN

Dist: Flex24, Inc.

4020 Galt Ocean Mile, Ste. 1607

Ft. Lauderdale, FL 33308

Tel: 844.4.FLEX24

Formulated in USA

Made in China

FLEX24®

RECOVER NATURALLY

HAS NATURAL MEDICINE FOR PAIN RELIEF

LONG LASTING FOR INCREASED ACTIVITY

WATERPROOF, FLEXIBLE, STAYS ON ALL-DAY

TOPICAL ANALGESIC

contents: 1 tape roll, 2 in. x 16.4 ft. (5 cm x 5 m)

FLEX24 TAPE

camphor, menthol patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73218 -0 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41) (CAMPHOR (NATURAL) - UNII:N20 HL7Q9 41)

CAMPHOR (NATURAL)

3 g in 10 0 g

Flex24, Inc.

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

2.52 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ANGELICA DAHURICA RO O T (UNII: 1V6 3N2S9 72)

ATRACTYLO DES LANCEA RO O T (UNII: CAZ6 28 2J2O)

BO RNEO L (UNII: M8 9 NIB437X)

ANGELICA SINENSIS RO O T (UNII: B6 6 F4574UG)

CHO NDRO ITIN SULFATE ( BO VINE) (UNII: 6 IC1M3OG5Z)

GINGER (UNII: C5529 G5JPQ)

KAEMPFERIA GALANGA RO O T (UNII: 7B7U9 D12AI)

ACO NITUM KUSNEZO FFII RO O T (UNII: 3L29 I4K8 KX)

LEMO N (UNII: 24RS0 A9 8 8 O)

LIGUSTICUM SINENSE SUBSP. CHUANXIO NG RO O T (UNII: RR8 3T9 9 U9 7)

MINERAL O IL (UNII: T5L8 T28 FGP)

MO SCHUS BEREZO VSKII MUSK SAC RESIN (UNII: Z70 MFY52S4)

PETRO LATUM (UNII: 4T6 H12BN9 U)

ACO NITUM NAPELLUS RO O T (UNII: KPD2N7348 X)

RO SIN (UNII: 8 8 S8 7KL8 77)

STAR ANISE (UNII: XKC16 57P78 )

METHYL SALICYLATE (UNII: LAV5U50 22Y)

ZINC O XIDE (UNII: SOI2LOH54Z)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:73218 -0 0 4-0 1

1 in 1 PACKAGE

0 9 /16 /20 19

1

1.56 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 9 /16 /20 19

Labeler -

Flex24, Inc. (117114024)

Revised: 9/2019

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