NEUROCOMFORT PAIN RELIEF- neurocomfort lotion NEUROCOMFORT PAIN RELIEF ROLL-ON- neuro comfort roll-on gel NEUROCOMFORT PAIN RELIEF GEL EXTRA STRENGTH- neuro comfort gel extra strength gel NEUROCOMFORT PAIN RELIEF GEL- neuro comfort gel gel NEUROCOMFORT PAIN RELIEF ROLL-ON EXTRA STRENGTH- neuro comfort roll-on extra strength gel

NeuroComfort Pain Relief Roll-on Extra Strength by

Drug Labeling and Warnings

NeuroComfort Pain Relief Roll-on Extra Strength by is a Otc medication manufactured, distributed, or labeled by ABACUS HEALTH PRODUCTS, INC., Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

For NDC:

73096-021 NeuroComfort Pain Relief

Active ingredient Lidocaine 2%

Inactive ingredients Arnica Montana Flower Extract, Capsaicin, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Symphytum Officinale (Comfrey) Leaf Extract, Water

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

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

Uses: For the temporary relief of minor pain

Purpose Lidocaine 2%............................................................................Topical Analgesic

Directions for 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

Warnings: For external use only

For NDC:

73096-022 NeuroComfort Pain Relief Gel

Active ingredient Lidocaine 2%

Inactive ingredients Arnica Montana Flower Extract, Capsaicin, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Symphytum Officinale (Comfrey) Leaf Extract, Water

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

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

Uses: For the temporary relief of minor pain

Purpose Lidocaine 2%............................................................................Topical Analgesic

Directions for 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

Warnings: For external use only

For NDC:

73096-023 NeuroComfort Pain Relif Gel Extra Strength

Active ingredient Lidocaine 2.25%

Inactive ingredients Arnica Montana Flower Extract, Capsaicin, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Symphytum Officinale (Comfrey) Leaf Extract, Water

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

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

Uses: For the temporary relief of minor pain

Purpose Lidocaine 2.25%............................................................................Topical Analgesic

Directions for 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

For NDC:

73096-024 NeuroComfort Pain Relief Roll-on

Active ingredient Lidocaine 2%

Inactive ingredients Arnica Montana Flower Extract, Capsaicin, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Symphytum Officinale (Comfrey) Leaf Extract, Water

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

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

Uses: For the temporary relief of minor pain

Purpose Lidocaine 2%............................................................................Topical Analgesic

Directions for 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

Warnings: For external use only

For NDC:

73096-025 NeuroComfort Pain Relief Roll-on Extra Strength

Active ingredient Lidocaine 2.25%

Inactive ingredients Arnica Montana Flower Extract, Capsaicin, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Symphytum Officinale (Comfrey) Leaf Extract, Water

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

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

Uses: For the temporary relief of minor pain

Purpose Lidocaine 2.25%............................................................................Topical Analgesic

Directions for 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

Warnings: For external use only

INGREDIENTS AND APPEARANCE

NEUROCOMFORT PAIN RELIEF 
neurocomfort lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4534 mg  in 226.7 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
EUCALYPTUS OIL (UNII: 2R04ONI662)
COMFREY LEAF (UNII: DG4F8T839X)
DIMETHICONE 1000 (UNII: MCU2324216)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAPSAICIN (UNII: S07O44R1ZM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HEMP (UNII: TD1MUT01Q7)	500 mg  in 226.7 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-021-01	226.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/10/2019

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

NEUROCOMFORT PAIN RELIEF ROLL-ON 
neuro comfort roll-on gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	1701 mg  in 85.05 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
COMFREY LEAF (UNII: DG4F8T839X)
DIMETHICONE 1000 (UNII: MCU2324216)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAPSAICIN (UNII: S07O44R1ZM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HEMP (UNII: TD1MUT01Q7)	500 mg  in 85.05 g
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-024-02	1 in 1 CARTON	07/10/2019
1	NDC: 73096-024-01	85.05 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 not final	part348	07/10/2019

NEUROCOMFORT PAIN RELIEF GEL EXTRA STRENGTH 
neuro comfort gel extra strength gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2169 mg  in 96.4 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
COMFREY LEAF (UNII: DG4F8T839X)
DIMETHICONE 1000 (UNII: MCU2324216)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAPSAICIN (UNII: S07O44R1ZM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HEMP (UNII: TD1MUT01Q7)	1000 mg  in 96.4 g
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-023-02	1 in 1 CARTON	07/10/2019
1	NDC: 73096-023-01	96.4 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

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

NEUROCOMFORT PAIN RELIEF GEL 
neuro comfort gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	1928 mg  in 96.4 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
COMFREY LEAF (UNII: DG4F8T839X)
DIMETHICONE 1000 (UNII: MCU2324216)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAPSAICIN (UNII: S07O44R1ZM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HEMP (UNII: TD1MUT01Q7)	500 mg  in 96.4 g
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-022-02	1 in 1 CARTON	07/10/2019
1	NDC: 73096-022-01	96.4 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 not final	part348	07/10/2019

NEUROCOMFORT PAIN RELIEF ROLL-ON EXTRA STRENGTH 
neuro comfort roll-on extra strength gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	1914 mg  in 85.05 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
COMFREY LEAF (UNII: DG4F8T839X)
DIMETHICONE 1000 (UNII: MCU2324216)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAPSAICIN (UNII: S07O44R1ZM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HEMP (UNII: TD1MUT01Q7)	1000 mg  in 85.05 g
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-025-02	1 in 1 CARTON	07/10/2019
1	NDC: 73096-025-01	85.04 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 not final	part348	07/10/2019

Labeler - Harmony Products LLC (117041828)

Registrant - Steuart Custom Manufacturing (116952121)

Establishment
Name	Address	ID/FEI	Business Operations
Steuart Custom Manufacturing		116952121	manufacture(73096-021, 73096-022, 73096-023, 73096-024, 73096-025)