FLEX24 TAPE- camphor, menthol patch

Flex24 Tape by

Drug Labeling and Warnings

Flex24 Tape by is a Otc medication manufactured, distributed, or labeled by Flex24, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Camphor, 3%

Menthol, 2.52%

Purpose

Topical Analgesic

Uses

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

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

FLEX24 TAPE 
camphor, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73218-004
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: 73218-004-01	1 in 1 PACKAGE	09/16/2019
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	09/16/2019

Labeler - Flex24, Inc. (117114024)