Harmony Hemp Flexible Pain Relief Roll-on 1000

Menthol Usp, 4%

Abacus Health Products, Inc.
Human Otc Drug
NDC 73096-075

Harmony Hemp Flexible Pain Relief Roll-on 1000 also known as Menthol Usp, 4% is a human otc drug labeled by 'Abacus Health Products, Inc.'. National Drug Code (NDC) number for Harmony Hemp Flexible Pain Relief Roll-on 1000 is 73096-075. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Harmony Hemp Flexible Pain Relief Roll-on 1000 drug includes Menthol, Unspecified Form - 2832 mg/70.8g . The currest status of Harmony Hemp Flexible Pain Relief Roll-on 1000 drug is Active.

Drug Information:

Drug NDC:	73096-075
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 Flexible 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:	Menthol 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:	MENTHOL, UNSPECIFIED FORM - 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:	26 Jun, 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.
UNII:	L7T10EIP3A
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
73096-075-02	1 BOTTLE, WITH APPLICATOR in 1 CARTON (73096-075-02) / 70.8 g in 1 BOTTLE, WITH APPLICATOR (73096-075-01)	26 Jun, 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 Flexible Pain Relief Roll-on 500

Menthol Usp, 4%

Gel
Abacus Health Products, Inc.
NDC: 73096-074

Harmony Hemp Flexible Pain Relief Gel 1000

Menthol Usp, 4%

Gel
Abacus Health Products, Inc.
NDC: 73096-073

Harmony Hemp Flexible Pain Relief Roll-on 1000

Menthol Usp, 4%

Gel
Abacus Health Products, Inc.
NDC: 73096-075

Harmony Hemp Flexible Pain Relief Lotion500

Menthol Usp, 4%

Lotion
Abacus Health Products, Inc.
NDC: 73096-071

Purpose:

Menthol usp, 4%.....................topical analgesic

Menthol, usp, 4%................................topical analgesic

Menthol usp, 4%...........................topical analgesic

Menthol usp, 4%......................topical analgesic

Product Elements:

Harmony hemp flexible pain relief roll-on 500 menthol usp, 4% yellow wax water cottonseed oil cannabis sativa seed oil polawax polysorbate eucalyptus globulus leaf clove oil tea tree oil peppermint oil shea butter jojoba oil sorbic acid menthol, unspecified form menthol, unspecified form harmony hemp flexible pain relief gel 500 pain relief gel fd&c yellow no. 5 arctium lappa root arnica montana flower water fd&c blue no. 1 frankincense calendula officinalis flower green tea leaf camphor, (-)- carbomer homopolymer, unspecified type glycerin ilex paraguariensis leaf isopropyl alcohol isopropyl myristate melissa officinalis leaf silicon dioxide .alpha.-tocopherol acetate hemp trolamine menthol, unspecified form menthol, unspecified form aloe vera leaf harmony hemp flexible pain relief lotion500 menthol usp, 4% yellow wax cottonseed oil polawax polysorbate eucalyptus globulus leaf water clove oil tea tree oil peppermint oil shea butter jojoba oil sorbic acid cannabis sativa seed oil menthol, unspecified form menthol, unspecified form harmony hemp flexible pain relief roll-on 1000 menthol usp, 4% yellow wax water cottonseed oil cannabis sativa seed oil polawax polysorbate eucalyptus globulus leaf clove oil tea tree oil peppermint oil shea butter jojoba oil sorbic acid menthol, unspecified form menthol, unspecified form harmony hemp flexible pain relief gel 1000 menthol usp, 4% fd&c yellow no. 5 arctium lappa root arnica montana flower water fd&c blue no. 1 frankincense calendula officinalis flower green tea leaf camphor, (-)- carbomer homopolymer, unspecified type glycerin ilex paraguariensis leaf isopropyl alcohol isopropyl myristate melissa officinalis leaf silicon dioxide .alpha.-tocopherol acetate hemp trolamine menthol, unspecified form menthol, unspecified form aloe vera leaf

Indications and Usage:

Temporarily relieves minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps

Temporary relief of minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Warnings:

For external use only when using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight. stop use and ask a doctor if condition worsens blistering or burning occurs pain or swelling occurs symptoms persist for more than 7 days or 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.

For external use only when using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken, or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight stop use and ask a doctor if condition worsens blistering or burning occurs pain or swelling occurs symptoms persist for more than 7 days or 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.

For external use only do not use on wounds or damaged skin when using this product avoid contact with eyes and mucous membranes do not bandage tightly or use with a heating pad 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 excessive skin irritation develops 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.

âfor external use only do not use on wounds or damaged skin when using this product avoid contact with eyes and mucous membranes do not bandage tightly or use with a heating pad 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 excessive skin irritation develops âdo 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:

For external use only when using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken, or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight stop use and ask a doctor if condition worsens blistering or burning occurs pain or swelling occurs symptoms persist for more than 7 days or 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.

When Using:

When using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight.

When using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken, or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight

When using this product avoid contact with eyes and mucous membranes do not bandage tightly or use with a heating pad

Dosage and Administration:

Adults and children 12 years of age and older apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 3 to 4 times daily 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 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

Package Label Principal Display Panel:

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For ndc 73096-072 harmony hemp flexible pain relief gel 500 harmony hemp flexible pain relief gel menthol 4% joint & muscle cbd moisturizing oil 500mg per bottle net wt 3 oz (85.05 g) menthol, usp, 4% menthol, usp, 4%................................topical analgesic temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps for external use only when using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken, or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight stop use and ask a doctor if condition worsens blistering or burning occurs pain or swelling occurs symptoms persist for more than 7 days or 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 children under 12 years of age: ask a doctor aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hemp extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica, tocopheryl acetate, triethanolamine, yellow 5, water questions or comments? 888-949-4367 2 3

For ndc 73096-073 harmony hemp flexible pain relief gel 1000 harmony hemp flexible pain relief gel menthol 4% joint & muscle cbd moisturizing oil 1000mg per bottle net wt 3 oz (85.05 g) menthol usp, 4% menthol usp, 4%...........................topical analgesic temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps for external use only when using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken, or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight stop use and ask a doctor if condition worsens blistering or burning occurs pain or swelling occurs symptoms persist for more than 7 days or 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 children under 12 years of age: ask a doctor aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hemp extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica, tocopheryl acetate, triethanolamine, yellow 5, water questions or comments? 888-949-4367 a s

For ndc 73096-074 harmony hemp flexible pain relief roll-on 500 harmony hemp flexible pain relief roll-on menthol 4% joint & muscle cbd moisturizing oil 500mg per bottle net wt 2.5 oz (70.8 g) menthol usp, 4% menthol usp, 4%......................topical analgesic temporary relief of minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains for external use only do not use on wounds or damaged skin when using this product avoid contact with eyes and mucous membranes do not bandage tightly or use with a heating pad 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 excessive skin irritation develops 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 beeswax, cbd hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid, water questions or comments? 888-949-4367 q w

For ndc 73096-075 harmony hemp flexible pain relief roll-on 1000 harmony hemp flexible pain relief roll-on menthol 4% joint & muscle cbd moisturizing oil 1000mg per bottle net wt 2.5 oz (70.8 g) menthol usp, 4% menthol usp, 4%......................topical analgesic temporary relief of minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains âfor external use only do not use on wounds or damaged skin when using this product avoid contact with eyes and mucous membranes do not bandage tightly or use with a heating pad 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 excessive skin irritation develops âdo 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 beeswax, cbd hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid, water questions or comments? 888-949-4367 z x

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.