NDC 63940-150 Harmon Extra Strength Pain Relieving Roll-on

Menthol

NDC Product Code 63940-150

NDC 63940-150-03

Package Description: 89 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Harmon Extra Strength Pain Relieving Roll-on with NDC 63940-150 is a a human over the counter drug product labeled by Harmon Stores Inc.. The generic name of Harmon Extra Strength Pain Relieving Roll-on is menthol. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 808955.

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.

Harmon Extra Strength Pain Relieving Roll-on 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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: Harmon Stores Inc.
Labeler Code: 63940
FDA Application Number: part346 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-05-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-31-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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".

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Harmon Extra Strength Pain Relieving Roll-on Product Label Images

Harmon Extra Strength Pain Relieving Roll-on 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 3.5%

Purpose

Cooling Pain Relief

Uses

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

Warnings:

For external use only

Ask A Doctor Before Use If You Have:

Sensitive skin, are pregnant or breast feeding

When Using This Product:

• Avoid contact with eyes or mucous membranes  • Do not apply to wounds, damaged or irritated skin, or excessive irritation develops  • Do not bandage or use with heating pad or device, ointments, creams, sprays, liniments • Wash hands after with cool water

Stop Use And Ask A Doctor If:

Conditions worsens, symptoms persist more than 7 days, or clear up and recur

Keep Out Of Reach Of Children:

If ingested, get medical help. Contact Poison Control Center immediately.

Directions:

• Adults / children 2 years and older: Massage onto affected area up to 4 times daily  • Children under 2 years of age: Consult Physician

Other Information:

Store in cool dry place, lid closed tightly. Keep away from excessive heat or open flame

Inactive Ingredients:

Water, isopropyl alcohol, herbal extract (IIex paraguariensis), carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FD andC blue #1

Dist. By Harmon Stores, Inc.

Union, NJ 07083 USAHarmon Stores, Inc.Visit us at: www.facevalues.com12015 REV 1Harmon Satisfaction Guaranteed or Your Money Back

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