NDC 68233-801 Maxrevive Plaster

Menthol, Methyl Salicylate

NDC Product Code 68233-801

NDC 68233-801-01

Package Description: 3 PATCH in 1 BAG > 2.3 g in 1 PATCH

NDC 68233-801-02

Package Description: 5 PATCH in 1 BAG > 1.7 g in 1 PATCH

NDC Product Information

Maxrevive Plaster with NDC 68233-801 is a a human over the counter drug product labeled by Albert Max, Inc.. The generic name of Maxrevive Plaster is menthol, methyl salicylate. The product's dosage form is patch and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1874174 and 1874179.

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.

Maxrevive Plaster 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.

  • CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)
  • RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
  • MYRRH (UNII: JC71GJ1F3L)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • SESAME OIL (UNII: QX10HYY4QV)
  • PINUS MASSONIANA RESIN (UNII: 64S07U83T7)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • YELLOW OB (UNII: QE535CBH7S)
  • 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.
  • 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: Albert Max, Inc.
Labeler Code: 68233
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: 09-01-2003 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.

Maxrevive Plaster Product Label Images

Maxrevive Plaster 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

Menthol 4%Methyl Salicylate 1%

Purpose

External Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:•arthritis •strains •bruises •sprains •simple backache

Warnings

For external use onlyDo not use•on wounds •irritated or damaged skin•sensitive skin •with a heating pad •if pregnant •with, or as the same time as, other external analgesic products•if allergic to aspirin or salicylates•if allergic to any ingredients of this productWhen using this product•avoid contact with the eyes•do not bandage tightly•do not apply to wounds or damaged skin•do not use more than 3 plasters a day•do not use 1 hour before or after bathingStop use and ask a doctor if•condition worsens•symptoms persist for more than 7 days•symptoms clear up and occur again within a few days•excessive irritation of the skin develops•rashes, itching or redness are present•side effects occur.If pregnant, ask a health professional before use.

Directions

•Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.•Plaster will remain effective for 8 hours.•Avoid using the same patch on the same area for more than 2 days.•Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.•Wet patch with warm water before removing from skin.•Children under 12 years of age: Do not use or consult a doctor.

Other Information

•Store unused patch in the pouch•Store at room temperature, 20 to 25° C(68 to 77° F)

Inactive Ingredients

Chinese Clematidis Root & Rhizome, Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No. 2, FD&C Yellow No. 4, Zinc Oxide

* Please review the disclaimer below.