NDC 61010-1550 Pain Relieving Roll-on

Menthol, Unspecified Form

NDC Product Code 61010-1550

NDC 61010-1550-1

Package Description: 88 mL in 1 BOTTLE

NDC Product Information

Pain Relieving Roll-on with NDC 61010-1550 is a a human over the counter drug product labeled by Safetec Of America, Inc.. The generic name of Pain Relieving Roll-on is menthol, unspecified form. The product's dosage form is gel and is administered via topical form.

Labeler Name: Safetec Of America, Inc.

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.

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.

  • MENTHOL, UNSPECIFIED FORM 7 g/100mL

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.

  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • WATER (UNII: 059QF0KO0R)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Safetec Of America, Inc.
Labeler Code: 61010
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: 10-07-2019 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.

Pain Relieving Roll-on Product Label Images

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

Other

Drug Facts

Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses

Temporary relief of minor aches and pains of muscles and joints.

Warnings

For external use only. Flammable.

Keep Away From Flame. Keep Out Of Reach Of Children.

If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly.
Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Directions

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information

Store at room temperature.

Inactive Ingredients

Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Methyl Salicylate, Purified Water, Tea Tree Oil, Xanthan Gum.

* Please review the disclaimer below.