NDC 61919-577 Lidopro

Lidopro

NDC Product Code 61919-577

NDC Product Information

Lidopro with NDC 61919-577 is a a human over the counter drug product labeled by Directrx. The generic name of Lidopro is lidopro. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Directrx

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.

Lidopro 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.

  • LIDOCAINE HYDROCHLORIDE .04 g/g
  • CAPSAICIN .000325 g/g
  • MENTHOL .1 g/g
  • METHYL SALICYLATE .275 g/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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CHAMOMILE (UNII: FGL3685T2X)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Directrx
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: 04-25-2019 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.

Lidopro Product Label Images

Lidopro 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

Otc - Active Ingredient

Capsaicin 0.0325%

Lidocaine HCL 4%

Menthol 10%

Methyl Salicylate 27.5%

Otc - Purpose

Lidocaine HCL 4%

Indications & Usage

Temporarily relieves minor aches and muscles pains associated with:arthritis

simple back pain

strains

muscle soreness

Warnings

For external use onlyDo not useon open wounds, cuts, damaged or infected skin

with bandage or a heating pad

if condition worsens or symptoms persists for more than 7 days

excessive skin irritation occurs
Ask a doctor before use ifyou are allergic to any ingredients, PABA, aspirin products or sulfaWhen using this productavoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.If pregnant or breast feeding,ask a health professional before use.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.Storeat 20○C - 25○C (68○F - 77○F)

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
Children 12 years or younger: ask a doctor

Inactive Ingredient

Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.For Questions or CommentsPlease Email info@TerrainRX.comManufactured for

Terrain Pharmaceuticals

Reno, NV 89501
Made in the U.S.A.

Patent Pending

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. Package not child resistant.

* Please review the disclaimer below.

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