Harmony Hemp NeuroComfort Pain Relief Gel 500 by Abacus Health Products, Inc. / Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions / Inspec Solutions NeuroComfort Line

Harmony Hemp NeuroComfort Pain Relief Gel 500 by

Drug Labeling and Warnings

Harmony Hemp NeuroComfort Pain Relief Gel 500 by is a Otc medication manufactured, distributed, or labeled by Abacus Health Products, Inc., Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions, Inspec Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HARMONY HEMP NEUROCOMFORT PAIN RELIEF LOTION500- lidocaine hcl usp, 4% lotion 
HARMONY HEMP NEUROCOMFORT PAIN RELIEF GEL 1000- lidocaine hcl usp, 4% gel 
HARMONY HEMP NEUROCOMFORT PAIN RELIEF ROLL-ON 1000- lidocaine hcl usp, 4% gel 
HARMONY HEMP NEUROCOMFORT PAIN RELIEF ROLL-ON 500- lidocaine hcl usp, 4% gel 
HARMONY HEMP NEUROCOMFORT PAIN RELIEF GEL 500- lidocaine hcl usp, 4% gel 
Abacus Health Products, Inc.

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NeuroComfort Line

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 usein 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

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 usein 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

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 usein 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

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 usein 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

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 usein 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

HARMONY HEMP NEUROCOMFORT PAIN RELIEF LOTION500 
lidocaine hcl usp, 4% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	9068 mg  in 226.7 g

Inactive Ingredients
Ingredient Name	Strength
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)
SHEA BUTTER (UNII: K49155WL9Y)
SORBIC ACID (UNII: X045WJ989B)
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)	500 mg  in 226.7 g
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-065-01	226.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/10/2019	12/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/10/2019	12/22/2023

HARMONY HEMP NEUROCOMFORT PAIN RELIEF GEL 1000 
lidocaine hcl usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	3402 mg  in 85.05 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARETH-21 (UNII: 53J3F32P58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEMP (UNII: TD1MUT01Q7)	1000 mg  in 85.05 g
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-067-02	1 in 1 CARTON	07/10/2019	12/22/2023
1	NDC: 73096-067-01	85.05 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/10/2019	12/22/2023

HARMONY HEMP NEUROCOMFORT PAIN RELIEF ROLL-ON 1000 
lidocaine hcl usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2832 mg  in 70.8 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARETH-21 (UNII: 53J3F32P58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEMP (UNII: TD1MUT01Q7)	1000 mg  in 70.8 g
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-069-02	1 in 1 CARTON	07/10/2019	12/22/2023
1	NDC: 73096-069-01	70.8 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/10/2019	12/22/2023

HARMONY HEMP NEUROCOMFORT PAIN RELIEF ROLL-ON 500 
lidocaine hcl usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2832 mg  in 70.8 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARETH-21 (UNII: 53J3F32P58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEMP (UNII: TD1MUT01Q7)	500 mg  in 70.8 g
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-068-02	1 in 1 CARTON	07/10/2019	12/22/2023
1	NDC: 73096-068-01	70.8 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/10/2019	12/22/2023

HARMONY HEMP NEUROCOMFORT PAIN RELIEF GEL 500 
lidocaine hcl usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	3402 mg  in 85.05 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARETH-21 (UNII: 53J3F32P58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEMP (UNII: TD1MUT01Q7)	500 mg  in 85.05 g
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-066-02	1 in 1 CARTON	07/10/2019	12/22/2023
1	NDC: 73096-066-01	85.05 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/10/2019	12/22/2023

Labeler - Abacus Health Products, Inc. (116931574)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions		018950611	manufacture(73096-065)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(73096-066, 73096-067, 73096-068, 73096-069)

Revised: 12/2023

Document Id: 0d99e316-e5fc-fe8e-e063-6294a90a6a0e

34390-5

Set id: bc03a3d8-fdb6-15d3-e053-2995a90a8832

Version: 6

Effective Time: 20231228