NDC 73218-003 Flex24 Pain Pen

Camphor

NDC Product Code 73218-003

NDC 73218-003-01

Package Description: 18 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Flex24 Pain Pen with NDC 73218-003 is a a human over the counter drug product labeled by Flex24, Inc.. The generic name of Flex24 Pain Pen is camphor. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Flex24, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 Pen 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) 7.79 g/100mL

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.

  • 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)

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 Pen Product Label Images

Flex24 Pain Pen 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 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.

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 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 dayChildren 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

Other

FLEX24®RECOVER NATURALLYDist: FLEX24, INC.        4020 Galt Ocean Mile, Ste. 1607        Ft. Lauderdale, FL 33308        Tel.: 844.4.FLEX24Formulated in USAMade in China

* Please review the disclaimer below.