FLEX24 PAIN- camphor, menthol patch

Flex24 Pain by

Drug Labeling and Warnings

Flex24 Pain 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 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

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 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 should be comfortable but not tight
• Sensitive skin – Remove patch under water

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

SPL UNCLASSIFIED SECTION

Download the FLEX24 App

Dist: FLEX24, INC.

        4020 Galt Ocean Mile, Ste. 1607

        Ft. Lauderdale, FL 33308

       Tel: 844.4.FLEX24

Formulated in the USA

PRINCIPAL DISPLAY PANEL

FLEX24.COM

FLEX24®

RECOVER NATURALLY

TOPICAL ANALGESIC PAIN PATCH

24 Hour Relief

7 Large Patches

Patch size 8 cm x 13 cm

All Natural

Long Lasting

Reduces Pain

Strong Natural Pain Relief

INGREDIENTS AND APPEARANCE

FLEX24 PAIN 
camphor, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73218-002
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: 73218-002-01	7 in 1 PACKAGE	08/28/2019
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	08/28/2019

Labeler - FLEX24 INC (117114024)