NDC 73218-002 Flex24 Pain

Camphor, Menthol

NDC Product Code 73218-002

NDC 73218-002-01

Package Description: 7 PATCH in 1 PACKAGE > 1.56 g in 1 PATCH

NDC Product Information

Flex24 Pain with NDC 73218-002 is a a human over the counter drug product labeled by Flex24 Inc. The generic name of Flex24 Pain is camphor, menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Flex24 Inc

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Flex24 Pain Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAMPHOR (NATURAL) 3 g/100g
  • MENTHOL 2.52 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Flex24 Inc
Labeler Code: 73218
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-28-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Flex24 Pain Product Label Images

Flex24 Pain Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

Otc - Do Not Use

  • Do notApply to open wounds, or damaged, broken, or irritated skin

Otc - Stop Use

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.

Warnings And Precautions

  • CautionDiscontinue use if excessive irritation of the skin developsAvoid contact with the eyes and mucous membranesArthritis: 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

Otc - 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 discardApply one patch to affected areaRepeat if necessary, but no more than 3 per dayPatch should be comfortable but not tightSensitive skin – Remove patch under waterChildren 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

Other

Download the FLEX24 AppDist: FLEX24, INC.        4020 Galt Ocean Mile, Ste. 1607        Ft. Lauderdale, FL 33308       Tel: 844.4.FLEX24Formulated in the USA

* Please review the disclaimer below.