NDC 61919-851 Transderm-iq

Transderm-iq

NDC Product Code 61919-851

NDC Product Information

Transderm-iq with NDC 61919-851 is a a human over the counter drug product labeled by Direct_rx. The generic name of Transderm-iq is transderm-iq. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Direct_rx

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Transderm-iq 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.

  • CAPSAICIN .0375 g/100g
  • MENTHOL, UNSPECIFIED FORM 10 g/100g
  • METHYL SALICYLATE 20 g/100g
  • LIDOCAINE 4 g/100g

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)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

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: Direct_rx
Labeler Code: 61919
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: 07-25-2019 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.

Transderm-iq Product Label Images

Transderm-iq 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

Warnings

For external use onlyuse only as directed. Read and follow all directions and warnings on this carton.

avoid contact with eyes and mucous membranes

do not use at the same time as other topical analgesics

do not use on open wounds, cuts, damaged or infected skin

do not use with bandage or heating pad.
Stop use and ask a doctor ifcondition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding or if you have sensitive skin, ask a health professional before use

Inactive Ingredient

Purified Water, Mineral Oil, Isopropyl Myristate, Cetyl Alcohol, Glycerol Monostearate, Stearic Acid, Glycerin, Propylene Glycol, Cetereth-20, Carbomer, Aloe Vera, Disodium EDTA, Dimethicone, Petrolatum, Methylparaben, Triethanolamine, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Propylparaben, Beeswax, Sodium Carbomer, Phenonip, Triethanolamine.

Other

New Hands Free Applicator(Quad-5 Ball Roller)Long Lasting and Soothing Deep Penetrating Action

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact Poison Control Center right away

Otc - Purpose

Topical analgesic

Otc - Active Ingredient

Capsaicin 0.0375%Lidocaine 4%Menthol 10%Methyl Salicylate 20%

Indications & Usage

Temporary relief of minor aches and pains of muscles and joints associated with:• simple backache • arthritis • muscle strains • sprains • bruises

Dosage & Administration

Adults 18 years and children 12 years and older:apply product directly to affected area

product may be used as necessary, but should not be used more than four times per day

wash hands immediately afterwards.

* Please review the disclaimer below.

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