DailyMed - 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

NDC Code(s): 73096-065-01, 73096-066-01, 73096-066-02, 73096-067-01, view more
73096-067-02, 73096-068-01, 73096-068-02, 73096-069-01, 73096-069-02
Packager: Abacus Health Products, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 23, 2021

If you are a consumer or patient please visit this version.

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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

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
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
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
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

INGREDIENTS AND APPEARANCE

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/10/2019

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/10/2019

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/10/2019

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/10/2019

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/10/2019

Labeler - Abacus Health Products, Inc. (116931574)

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

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

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	NDC
1	73096-065-01
2	73096-066-01
3	73096-066-02
4	73096-067-01
5	73096-067-02
6	73096-068-01
7	73096-068-02
8	73096-069-01
9	73096-069-02

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