NDC 63400-1601 Flexall Pain Relieving

Menthol Analgesic

NDC Product Code 63400-1601

NDC 63400-1601-4

Package Description: 453 g in 1 BOTTLE

NDC 63400-1601-5

Package Description: 3170 g in 1 BOTTLE, PUMP

NDC Product Information

Flexall Pain Relieving with NDC 63400-1601 is a a human over the counter drug product labeled by Ari-med Pharmaceuticals. The generic name of Flexall Pain Relieving is menthol analgesic. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1087516 and 311509.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Flexall Pain Relieving 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • ALCOHOL (UNII: 3K9958V90M)
  • STEARETH-2 (UNII: V56DFE46J5)
  • STEARETH-21 (UNII: 53J3F32P58)
  • THYME OIL (UNII: 2UK410MY6B)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Ari-med Pharmaceuticals
Labeler Code: 63400
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: 01-01-1997 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Flexall Pain Relieving 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

Menthol 7%

Purpose

Topical analgesic

Uses

  • Temporarily relieves minor pain associated with:arthritis
  • Simple backache
  • Muscle strains
  • Sprains
  • Bruises
  • Cramps

Warnings

For external use onlyAllergy alert: Do not use if you are allergic to salicylates (including aspirin) unless directed by a doctor.

When Using This Product

  • Use only as directed. Read and follow all directions and warnings on this label.
  • Rare cases of serious burns have been reported with products of this type
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged, broken or irritated skindo not use at the same time as other topical analgesics

Stop Use And Ask A Doctor If

  • Condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children over 12 years: apply generously to affected area
  • Massage into painful area until thoroughly absorbed into skin
  • Repeat as necessary, but no more than 3 to 4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATERchildren 12 years or younger: ask a doctor

Inactive Ingredients

Allantoin, aloe barbadensis leaf juice, carbomer, eucalyptus globulus leaf oil, glycerin, mentha piperita (peppermint) oil, methyl salicylate, SD alcohol 40 (15%), steareth-2, steareth-21, thymus vulgaris (thyme) oil, tocopheryl acetate, triethanolamine, water

* Please review the disclaimer below.