NDC 73096-001 Neurocomfort Pain Relief

Pain Relief Lotion

NDC Product Code 73096-001

NDC Code: 73096-001

Proprietary Name: Neurocomfort Pain Relief 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: Pain Relief Lotion 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

  • 73096 - Harmony Products Llc
    • 73096-001 - Neurocomfort Pain Relief

NDC 73096-001-01

Package Description: 226.7 g in 1 BOTTLE, DISPENSING

NDC Product Information

Neurocomfort Pain Relief with NDC 73096-001 is a a human over the counter drug product labeled by Harmony Products Llc. The generic name of Neurocomfort Pain Relief is pain relief lotion. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Harmony Products Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Neurocomfort Pain Relief 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, UNSPECIFIED FORM 4530 mg/226.7g

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • HEMP (UNII: TD1MUT01Q7)
  • DIMETHICONE 1000 (UNII: MCU2324216)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • 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: Harmony Products Llc
Labeler Code: 73096
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 06-27-2019 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.

Neurocomfort Pain Relief 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

Recent Major Changes

Directions Adults and children 12 years of age and over: shake well apply to affected area not more than 4 times daily massage painful area until absorbed into skin wash hands after each use with cold water Children under 12 years of age: consult a doctorSee imagesUSESUses: For the temporary relief of minor aches and pains Arthritis, simple backache, strains, bruises, sprains

For Ndc 73096-002

Label for NDC 73096-002

Otc - Active Ingredient

Natural Menthol USP 2%...................................................................................................Topical Analgesic

Active ingredient PurposeNatural Menthol USP 2.5%................................................................................................Topical Analgesic

Active ingredient PurposeNatural Menthol USP 2%...................................................................................................Topical Analgesic

Warnings

Warnings For external use only Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient on open wounds, damaged irritated skin with a heating pad or TENS device after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes Other information store in a cool place away from direct sunlight store with lid closed tightly If pregnant or breast feeding, ask a health professional before use.

Warnings For external use only Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient on open wounds, damaged irritated skin with a heating pad or TENS device after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes Other information store in a cool place away from direct sunlight store with lid closed tightly 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.

Warnings For external use only Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient on open wounds, damaged irritated skin with a heating pad or TENS device after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes Other information store in a cool place away from direct sunlight store with lid closed tightly If pregnant or breast feeding, ask a health professional before use.

Otc - Ask Doctor

Stop use and ask a doctor if condition worsens rash, itching, redness or excessive irritation of the skin develops symptoms last more than 7 days symptoms clear up and occur again within a few days

Stop use and ask a doctor if condition worsens rash, itching, redness or excessive irritation of the skin develops symptoms last more than 7 days symptoms clear up and occur again within a few days

Stop use and ask a doctor if condition worsens rash, itching, redness or excessive irritation of the skin develops symptoms last more than 7 days symptoms clear up and occur again within a few days

Inactive Ingredient

Inactive ingredients arnica montana (arnica flower) extract, capsaicin, deionized water, dimethicone, eucalyptus globulus leaf oil, full spectrum hemp extract, glycerin, helianthus annuus (sunflower seed oil), laureth-7 c13-14 isoparaffin polyacrylamide, phenoxyethanolSee innactive

Inactive ingredients arnica montana (arnica flower) extract, capsaicin, deionized water, dimethicone, eucalyptus globulus leaf oil, full spectrum hemp extract, glycerin, helianthuss

Inactive ingredients arnica montana (arnica flower) extract, capsaicin, deionized water, dimethicone, eucalyptus globulus leaf oil, full spectrum hemp extract, glycerin, helianthus

Indications & Usage

Uses: For the temporary relief of minor aches and pains Arthritis, simple backache, strains, bruises, sprains

Uses: For the temporary relief of minor aches and painsarthritis simple backache strains bruises sprains

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.

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

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

Otc - Purpose

Active ingredient PurposeNatural Menthol USP 2%..................................................................................................
Topical Analgesic

Active ingredient PurposeNatural Menthol USP 2.5%................................................................................................
Topical Analgesic

Active ingredient PurposeNatural Menthol USP 2%...................................................................................................
Topical Analgesic

Dosage & Administration

Directions Adults and children 12 years of age and over: shake well apply to affected area not more than 4 times daily massage painful area until absorbed into skin wash hands after each use with cold water Children under 12 years of age: consult a doctor

Directions Adults and children 12 years of age and over: shake well apply to affected area not more than 4 times daily massage painful area until absorbed into skin wash hands after each use with cold water Children under 12 years of age: consult a doctor

DirectionsAdults and children 12 years of age and over:shake well apply to affected area not more than 4 times daily massage painful area untilabsorbed into skin wash hands after each use with cold waterChildren under 12 years of age: consult a doctor

For Ndc 73096-003

Label for NDC 73096-003

For Ndc 73096-001

For NDC 73096-001

* Please review the disclaimer below.

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