NDC 63742-007 Arnicool

Menthol

NDC Product Code 63742-007

NDC 63742-007-00

Package Description: 65 g in 1 JAR

NDC 63742-007-01

Package Description: 130 g in 1 JAR

NDC Product Information

Arnicool with NDC 63742-007 is a a human over the counter drug product labeled by Clinical Resolution Laboratory, Inc.. The generic name of Arnicool is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Clinical Resolution Laboratory, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Arnicool 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 40 mg/g

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)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLUCOSAMINE (UNII: N08U5BOQ1K)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • EMU (UNII: 97P687I7AP)
  • PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CAMPHOR OIL (UNII: 75IZZ8Y727)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • EUCALYPTUS GUM (UNII: 72T9EZC2VX)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

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: Clinical Resolution Laboratory, Inc.
Labeler Code: 63742
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: 05-15-2018 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 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.

Arnicool Product Label Images

Arnicool 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 4%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

Warnings

(For external use only)

Do Not Use This Product If

  • Tamper Evident "Do Not Use...Seal..."label atop the container is brokenPregnant or breastfeeding, ask a health professional before use

When Using This Product

  • Avoid contact with the eyes or mucous membranesDo not apply to wounds or damaged skinDo not use with other ointments, creams, sprays or linimentsDo not apply to irritated skin or if excessive irritation developsDo not bandageDo not use with heating pad or device

Stop Use And Ask A Doctor If

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reccur.

Keep Out Of Reach Of Children

In case of accidental overdose or if ingested, contact a doctor or Poison Control Center immediately.

Directions

  • Adults and children 12 years of age older: Apply liberally to the affected area(s) and continue to massage in thoroughly for 1-2 minutes until it has been absorbed. For best results, apply 2-3 times daily for 2 weeks, then as needed.Children under 12 years of age:consult a physician.

Other Information

  • Store in room temperature (59~86°F).

Inactive Ingredients

Water, Arnica Montana Flower Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Centella Asiatica Extract, Glycerin, Xanthan Gum, Glucosamine, Methylsulfonylmethane (MSM), Helianthus Annuus (Sunflower) Seed Oil, Dromiceius (Emu) Oil, Pyridoxine Hydrochloride (Vitamin B6), Butyrospermum Parkii (Shea) Butter, Dimethicone, Frankincense Serrata Oil, Lavandula Officinalis (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cinnamomum Camphora (Camphor) Bark Oil, Tocopherol, Dipotassium Glycyrrhizinate, Glyceryl Stearate / PEG-100 Stearate, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Ethoxydiglycol, Lecithin, Cholesterol, Phenoxyethanol, Disodium EDTA

* Please review the disclaimer below.