NDC 72594-1847 Neptune Ice Patch

Lidocaine, Menthol, Camphor, And Dimethicone Patch

NDC Product Code 72594-1847

NDC Code: 72594-1847

Proprietary Name: Neptune Ice Patch 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: Lidocaine, Menthol, Camphor, And Dimethicone Patch 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.

NDC Code Structure

  • 72594 - Neptune Products L.l.c.
    • 72594-1847 - Neptune Ice Patch

NDC 72594-1847-8

Package Description: 2 POUCH in 1 BOX > 5 PATCH in 1 POUCH > 15000 mg in 1 PATCH

NDC Product Information

Neptune Ice Patch with NDC 72594-1847 is a a human over the counter drug product labeled by Neptune Products L.l.c.. The generic name of Neptune Ice Patch is lidocaine, menthol, camphor, and dimethicone patch. The product's dosage form is patch and is administered via topical form.

Labeler Name: Neptune Products L.l.c.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Neptune Ice Patch 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.

  • CAMPHOR (NATURAL) 450 mg/mg
  • DIMETHICONE 450 mg/mg
  • LIDOCAINE 600 mg/mg
  • MENTHOL 150 mg/mg

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POVIDONE (UNII: FZ989GH94E)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • TARTARIC ACID (UNII: W4888I119H)

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: Neptune Products L.l.c.
Labeler Code: 72594
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: 04-12-2019 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.

Neptune Ice Patch Product Label Images

Neptune Ice Patch 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

Lidocaine 4%

Menthol 1%

Camphor 3%

Dimethicone 3%

Purpose

Topical Anesthetic

Topical Analgesic

Topical Analgesic

Skin Conditioner

Uses:

  • For the temporary relief of joint pain and muscle pain associated with:ArthritisBackacheCrampsDiscomfortNeckacheSorenessSprainsStrains

Warnings

For External Use Only

Flammable

Keep away from excessive heat or open flame

Do Not Use

  • On damaged or irritated skinWith a bandage or heating padIf you are allergic to any ingredients in this productOther than as directed

When Using This Product

Avoid contact with the eyes

Stop Use And Ask A Doctor If

  • Condition worsensExcessive skin irritation developsSymptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

If You Are Pregnant Or Breast Feeding

Ask a health professional before use

Keep Out Of Reach Of Children

If ingested, seek medical help or contact a Poison Control Center immediately

Directions

  • Adults and Children 12 years of Age and Older:Clean and dry the affected areaApply product directly to your skin, up to 4 times daily

Other Information

  • Store in a cool, dry place with lid tightly closed

Inactive Ingredients

Aloe Barbadensls Leaf Extract, Alcohol, Arnlca Montana Flower Extract, Boswellia Serrata Extracl Butylene Glycol Cellulose Gum Dihydroxyaluminum Aminoecstete, Blycerin, lsopropyl Myristate, Msttwlsulfonylmethene, Partially Neutralized Polyacrylate, Phenoxvethanol, Polvsorbate 80, Porvvinyl Pyrrolidone, Propylene Glycol, Tartaric Acid, Tetrasodium EDTA, Water.

* Please review the disclaimer below.

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