Harmony Hemp Neurocomfort Pain Relief Roll-on 1000

Lidocaine Hcl Usp, 4%

Abacus Health Products, Inc.
Human Otc Drug
NDC 73096-069

Harmony Hemp Neurocomfort Pain Relief Roll-on 1000 also known as Lidocaine Hcl Usp, 4% is a human otc drug labeled by 'Abacus Health Products, Inc.'. National Drug Code (NDC) number for Harmony Hemp Neurocomfort Pain Relief Roll-on 1000 is 73096-069. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Harmony Hemp Neurocomfort Pain Relief Roll-on 1000 drug includes Lidocaine - 2832 mg/70.8g . The currest status of Harmony Hemp Neurocomfort Pain Relief Roll-on 1000 drug is Active.

Drug Information:

Drug NDC:	73096-069
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Harmony Hemp Neurocomfort Pain Relief Roll-on 1000
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Lidocaine Hcl Usp, 4%
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Abacus Health Products, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	LIDOCAINE - 2832 mg/70.8g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	10 Jul, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	04 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part348
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Abacus Health Products, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175682 M0000897 N0000175426 N0000175976
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	98PI200987
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Amide Local Anesthetic [EPC] Antiarrhythmic [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Local Anesthesia [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Amides [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Amide Local Anesthetic [EPC] Amides [CS] Antiarrhythmic [EPC] Local Anesthesia [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
73096-069-02	1 BOTTLE, WITH APPLICATOR in 1 CARTON (73096-069-02) / 70.8 g in 1 BOTTLE, WITH APPLICATOR (73096-069-01)	10 Jul, 2019	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Harmony Hemp Neurocomfort Pain Relief Roll-on 500

Lidocaine Hcl Usp, 4%

Gel
Abacus Health Products, Inc.
NDC: 73096-068

Harmony Hemp Neurocomfort Pain Relief Gel 500

Lidocaine Hcl Usp, 4%

Gel
Abacus Health Products, Inc.
NDC: 73096-066

Harmony Hemp Neurocomfort Pain Relief Gel 1000

Lidocaine Hcl Usp, 4%

Gel
Abacus Health Products, Inc.
NDC: 73096-067

Harmony Hemp Neurocomfort Pain Relief Lotion500

Lidocaine Hcl Usp, 4%

Lotion
Abacus Health Products, Inc.
NDC: 73096-065

Harmony Hemp Neurocomfort Pain Relief Roll-on 1000

Lidocaine Hcl Usp, 4%

Gel
Abacus Health Products, Inc.
NDC: 73096-069

Purpose:

Lidocaine hcl usp, 4%.................topical analgesic

Lidocaine hcl usp, 4%...................topical anesthetic

Lidocaine hcl usp, 4%.......................topical anesthetic

Lidocaine hcl, 4%....................topical anesthetic

Lidocaine hcl, 4%........................topical anesthetic

Product Elements:

Harmony hemp neurocomfort pain relief lotion500 lidocaine hcl usp, 4% polawax polysorbate shea butter sorbic acid lidocaine lidocaine yellow wax water cannabis sativa seed oil cottonseed oil jojoba oil harmony hemp neurocomfort pain relief gel 1000 lidocaine hcl usp, 4% water alcohol methylparaben steareth-21 ethylhexylglycerin carbomer interpolymer type a (allyl sucrose crosslinked) aloe vera leaf aminomethylpropanol c30-45 alkyl methicone caprylyl trisiloxane glyceryl monostearate cetostearyl alcohol ceteth-20 phosphate dihexadecyl phosphate dimethicone hemp edetate disodium anhydrous lidocaine lidocaine harmony hemp neurocomfort pain relief roll-on 1000 lidocaine hcl usp, 4% water alcohol methylparaben steareth-21 ethylhexylglycerin carbomer interpolymer type a (allyl sucrose crosslinked) aloe vera leaf aminomethylpropanol c30-45 alkyl methicone caprylyl trisiloxane glyceryl monostearate cetostearyl alcohol ceteth-20 phosphate dihexadecyl phosphate dimethicone hemp edetate disodium anhydrous lidocaine lidocaine harmony hemp neurocomfort pain relief roll-on 500 lidocaine hcl usp, 4% water alcohol methylparaben steareth-21 ethylhexylglycerin carbomer interpolymer type a (allyl sucrose crosslinked) aloe vera leaf aminomethylpropanol c30-45 alkyl methicone caprylyl trisiloxane glyceryl monostearate cetostearyl alcohol ceteth-20 phosphate dihexadecyl phosphate dimethicone hemp edetate disodium anhydrous lidocaine lidocaine harmony hemp neurocomfort pain relief gel 500 lidocaine hcl usp, 4% water alcohol methylparaben steareth-21 ethylhexylglycerin carbomer interpolymer type a (allyl sucrose crosslinked) aloe vera leaf aminomethylpropanol c30-45 alkyl methicone caprylyl trisiloxane glyceryl monostearate cetostearyl alcohol ceteth-20 phosphate dihexadecyl phosphate dimethicone hemp edetate disodium anhydrous lidocaine lidocaine

Indications and Usage:

Temporary relief of pain

Temporarily relieves pain

Warnings:

For external use only do not use in large quantities, particularly over raw surfaces and blistered areas when using this product avoid contact with eyes and mucous membranes stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days do not use if pregnant or breastfeeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.

Warnings: for external use only do not use in large quantities, particularly over raw surfaces and blistered areas when using this product avoid contact with eyes and mucous membranes stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days do not use if pregnant or breastfeeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.

Do Not Use:

When Using:

When using this product avoid contact with eyes and mucous membranes

Dosage and Administration:

Adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily wash hands with soap and water after use (unless applying to hands) children under 12 years of age: ask a doctor

Adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily. wash hands with soap and water after use (unless applying to hands) children under 12 years of age: ask a doctor

Adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily wash hands with soap and water after use children under 12 years of age: ask a doctor

Stop Use:

Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days

Package Label Principal Display Panel:

For ndc 73096-065 harmony hemp neurocomfort pain relief lotion 500 harmony hemp neurocomfort pain relief lotion lidocaine hcl 4% hands & feet cbd moisturizing oil 500mg per bottle net wt 8 oz (226.7 g) lidocaine hcl usp, 4% lidocaine hcl usp, 4%.................topical analgesic temporary relief of pain for external use only do not use in large quantities, particularly over raw surfaces and blistered areas when using this product avoid contact with eyes and mucous membranes stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days do not use if pregnant or breastfeeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately. adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily wash hands with soap and water after use (unless applying to hands) children under 12 years of age: ask a doctor beeswax, cbd hemp oil, cottonseed oil, emulsifying wax, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid, water 1 questions or comments? 888-949-4367

For ndc 73096-066 harmony hemp neurocomfort pain relief gel 500 harmony hemp neurocomfort pain relief gel lidocaine hcl 4% hands & feet cbd moisturizing oil 500mg per bottle net wt 3 oz (85.05g) lidocaine hcl usp, 4% lidocaine hcl usp, 4%...................topical anesthetic temporary relief of pain warnings: for external use only do not use in large quantities, particularly over raw surfaces and blistered areas when using this product avoid contact with eyes and mucous membranes stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days do not use if pregnant or breastfeeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately. adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily. wash hands with soap and water after use (unless applying to hands) children under 12 years of age: ask a doctor acrylates/c10-30 alkyl acrylate cross polymer, aloe barbadensis leaf extract, aminomethyl propanol, c30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium edta, ethylhexylglycerin, glyceryl stearate, industrial hemp extract, methylparaben, sd alcohol 40, stealth-21, water questions or comments? 888-949-4367 2 3

For ndc 73096-067 harmony hemp neurocomfort pain relief gel 1000 harmony hemp neurocomfort pain relief gel lidocaine hcl 4% hands & feet cbd moisturizing oil 1000mg per bottle net wt 3 oz (85.05 g) lidocaine hcl usp, 4% lidocaine hcl usp, 4%.......................topical anesthetic temporary relief of pain for external use only do not use in large quantities, particularly over raw surfaces and blistered areas when using this product avoid contact with eyes and mucous membranes stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days do not use if pregnant or breastfeeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately. adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily. wash hands with soap and water after use (unless applying to hands) children under 12 years of age: ask a doctor acrylates/c10-30 alkyl acrylate cross polymer, aloe barbadensis leaf extract, aminomethyl propanol, c30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium edta, ethylhexylglycerin, glyceryl stearate, industrial hemp extract, methylparaben, sd alcohol 40, stealth-21, water questions or comments? 888-949-4367 4 5

For ndc 73096-068 harmony hemp neurocomfort pain relief roll-on 500 harmony hemp neurocomfort pain relief roll-on lidocaine hcl 4% hands & feet cbd moisturizing oil 500mg per bottle net wt 2.5 oz (70.8 g) lidocaine hcl, 4% lidocaine hcl, 4%....................topical anesthetic temporarily relieves pain warnings: for external use only do not use in large quantities, particularly over raw surfaces and blistered areas when using this product avoid contact with eyes and mucous membranes stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days do not use if pregnant or breastfeeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately. adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily wash hands with soap and water after use children under 12 years of age: ask a doctor acrylates/c10-30 alkyl acrylate cross polymer, aloe barbadensis leaf extract, aminomethyl propanol, c30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium edta, ethylhexylglycerin, glyceryl stearate, industrial hemp extract, methylparaben, sd alcohol 40, stealth-21, water questions or comments? 888-949-4367 a b

For ndc 73096-069 harmony hemp neurocomfort pain relief roll-on 1000 harmony hemp neurocomfort pain relief roll-on lidocaine hcl 4% hands & feet cbd moisturizing oil 1000mg per bottle net wt 2.5 oz (70.8 g) lidocaine hcl, 4% lidocaine hcl, 4%........................topical anesthetic temporarily relieves pain warnings: for external use only do not use in large quantities, particularly over raw surfaces and blistered areas when using this product avoid contact with eyes and mucous membranes stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days do not use if pregnant or breastfeeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately. adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily wash hands with soap and water after use children under 12 years of age: ask a doctor acrylates/c10-30 alkyl acrylate cross polymer, aloe barbadensis leaf extract, aminomethyl propanol, c30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium edta, ethylhexylglycerin, glyceryl stearate, industrial hemp extract, methylparaben, sd alcohol 40, stealth-21, water questions or comments? 888-949-4367 r s

Further Questions:

Questions or comments? 888-949-4367

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.