NDC 68233-811 Herbal

Menthol And Methyl Salicylate

NDC Product Code 68233-811

NDC 68233-811-01

Package Description: 32 mL in 1 BOTTLE

NDC Product Information

Herbal with NDC 68233-811 is a a human over the counter drug product labeled by Albert Max, Inc.. The generic name of Herbal is menthol and methyl salicylate. The product's dosage form is oil and is administered via topical form.

Labeler Name: Albert Max, Inc.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Herbal 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.

  • MENTHOL .1 g/mL
  • METHYL SALICYLATE .05 g/mL

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.

  • IMPATIENS BALSAMINA WHOLE (UNII: ZMK32KX641)
  • LICORICE (UNII: 61ZBX54883)
  • OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3)
  • SAFFLOWER (UNII: 4VBL71TY4Y)
  • SAPOSHNIKOVIA DIVARICATA WHOLE (UNII: LA61LWB4JH)
  • PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)
  • ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT)
  • SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
  • ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)
  • PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)
  • PAEONIA LACTIFLORA WHOLE (UNII: N44H57P7WG)
  • ALCOHOL (UNII: 3K9958V90M)
  • ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
  • CARPESIUM ABROTANOIDES FRUIT (UNII: 20C78R73NH)

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: 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: 06-05-2019 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.

Herbal Product Label Images

Herbal 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 10%Methyl Salicylate 5%

Purpose

External analgesic

Uses

  • Temporarily relieves minor aches and pains of muscles and joints due to:simple backachearthritisstrainsbruisessprains

Otc - Do Not Use

DO NOT USE if pregnant or breast-feeding.

Warnings And Precautions

For external use only

When Using This Product

  • Use only as directeddo not get into the eyes or mucous membranes do not apply to wounds or damaged skin do not bandage tightly

Stop Use And Ask A Doctor If

  • Excessive irritation developspain worsens or does not improve within 7 days or clears up and appears again in a few days

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: apply to affected area not more than 3 to 4 times dailyChildren under 2 years of age: ask a doctor

Inactive Ingredients

Saposhnikoviae Radix, Crossostephium Chinese, Moutan Radicis Cortex, Carpesii Fructus, Cimicifugae Rhizoma, Sophorae Flavescentis Radix, Herba Clematidis Intricatae, Paeoniae Rubra Radix, Zanthoxyli Pericarpium, Glycyrrhizae Radix Et Rhizoma, Ocimum Basilicum, Notoginseng Radix Et Rhizoma, Carthami Flos, Ethyl Alcohol

* Please review the disclaimer below.