NDC 70015-660 Instaflex Extra Strength Pain Relief Cream

Menthol, Methyl Salicylate

NDC Product Code 70015-660

NDC Code: 70015-660

Proprietary Name: Instaflex Extra Strength Pain Relief Cream What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol, Methyl Salicylate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 70015 - Healthy Directions, Llc
    • 70015-660 - Instaflex Extra Strength Pain Relief Cream

NDC 70015-660-02

Package Description: 1 TUBE in 1 CARTON > 57 g in 1 TUBE

NDC 70015-660-04

Package Description: 1 TUBE in 1 CARTON > 113 g in 1 TUBE

NDC Product Information

Instaflex Extra Strength Pain Relief Cream with NDC 70015-660 is a a human over the counter drug product labeled by Healthy Directions, Llc. The generic name of Instaflex Extra Strength Pain Relief Cream is menthol, methyl salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Healthy Directions, Llc

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.


Instaflex Extra Strength Pain Relief Cream 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 25 mg/g
  • METHYL SALICYLATE 100 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.

  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LAURETH-7 (UNII: Z95S6G8201)
  • CORN OIL (UNII: 8470G57WFM)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • WATER (UNII: 059QF0KO0R)

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: 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: 03-01-2019 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 Extra Strength Pain Relief Cream Product Label Images

Instaflex Extra Strength Pain Relief Cream 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

Otc - Active Ingredient

Active IngredientsMenthol (2.5%)Methyl Salicylate (10%)

Otc - Purpose

PurposeTopical Analgesic

Indications & Usage

  • Uses Temporarily relieves minor aches and pains of musclesand joints associated with: simple backachearthritis strains sprains bruises

Warnings

WarningsFor 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 haveredness 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.

Dosage & Administration

Directions Adults 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.

Storage And Handling

Other Information Keep product at room termperature andhumidity [59-86°F (15-30°C), 40% RH]. Do not freeze. For LotNumber and Expiration Date, see crimp at end of tube.

Inactive Ingredient

Inactive ingredients C13-14 Isoparaffin, Citrus Aurantium Dulcis (Orange) Oil, Ethylhexlglycerin, Eucalyptus Globulus Oil,Glyceryl Stearate, Laureth-7, Oxygenated Corn Oil, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Water

* Please review the disclaimer below.

Previous Code
70015-655
Next Code
70015-665