NDC 70015-670 Instaflex Pain Relief Roll-on

Menthol

NDC Product Code 70015-670

NDC 70015-670-25

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 71 g in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Instaflex Pain Relief Roll-on with NDC 70015-670 is a a human over the counter drug product labeled by Healthy Directions, Llc. The generic name of Instaflex Pain Relief Roll-on is menthol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Healthy Directions, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Instaflex Pain Relief 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 12.5 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.

  • CORN OIL (UNII: 8470G57WFM)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • WATER (UNII: 059QF0KO0R)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)

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: Healthy Directions, Llc
Labeler Code: 70015
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: 10-21-2019 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.

Instaflex Pain Relief Roll-on Product Label Images

Instaflex Pain Relief 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 (1.25%)

Purpose

Menthol (1.25%)....................Topical Analgesic

Uses

  • Temporarily relieves minor aches and pains of muscles and joints associated witharthritisstrainssprainsbruises

Warnings

For external use only

Otc - Do Not Use

  • Do not usewith a heating pad, may blister skinon open wounds or damaged skin

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area

Otc - When Using

  • When using this productUse only as directed avoid contact with eyes do not bandage tightly

Otc - Stop Use

  • Stop use and ask a doctor ifskin redness or excessive skin irritation developscondition worsens or symptoms persist for more than 7 days symptoms clear up and occur again in a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adult and children 12 years of age and older: Apply to affected area no more than 3-4 times daily.
Children under 12 years of age: Consult a doctor.

Other Information

Keep product at room termperature and humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. Lot Number and Expiration Date printed below.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Clyceryl Stearate SE, Oxygenated Corn Oil, Phenoxyethanol, Polysorbate-20, Sodium Hydroxide, Steareth-20, Water, Xanthan Gum, Zemea (Corn) Propanediol

* Please review the disclaimer below.