NeuroComfort Pain Relief Gel Extra Strength by Harmony Products LLC / Steuart Custom Manufacturing

NeuroComfort Pain Relief Gel Extra Strength by

Drug Labeling and Warnings

NeuroComfort Pain Relief Gel Extra Strength by is a Homeopathic medication manufactured, distributed, or labeled by Harmony Products LLC, Steuart Custom Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NEUROCOMFORT PAIN RELIEF- pain relief lotion lotion 
NEUROCOMFORT PAIN RELIEF GEL 500- pain relief gel gel 
NEUROCOMFORT PAIN RELIEF GEL EXTRA STRENGTH- pain relief gel extra strength gel 
Harmony Products LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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For NDC: 73096-002

Label for NDC: 73096-002

Natural Menthol USP 2%...................................................................................................Topical Analgesic

Warnings For external use only Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient on open wounds, damaged irritated skin with a heating pad or TENS device after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes Other information store in a cool place away from direct sunlight store with lid closed tightly If pregnant or breast feeding, ask a health professional before use.

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

Inactive ingredients arnica montana (arnica flower) extract, capsaicin, deionized water, dimethicone, eucalyptus globulus leaf oil, full spectrum hemp extract, glycerin, helianthus annuus (sunflower seed oil), laureth-7 c13-14 isoparaffin polyacrylamide, phenoxyethanol

See innactive

Uses: For the temporary relief of minor aches and pains Arthritis, simple backache, strains, bruises, sprains

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

Active ingredient Purpose

Natural Menthol USP 2%.................................................................................................. Topical Analgesic

Directions 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 Children under 12 years of age: consult a doctor

For NDC: 73096-003

Label for NDC: 73096-003

Active ingredient Purpose

Natural Menthol USP 2.5%................................................................................................Topical Analgesic

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

Warnings For external use only Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient on open wounds, damaged irritated skin with a heating pad or TENS device after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes Other information store in a cool place away from direct sunlight store with lid closed tightly If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions 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 Children under 12 years of age: consult a doctor

Inactive ingredients arnica montana (arnica flower) extract, capsaicin, deionized water, dimethicone, eucalyptus globulus leaf oil, full spectrum hemp extract, glycerin, helianthus

s

Uses: For the temporary relief of minor aches and pains

arthritis simple backache strains bruises sprains

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

Active ingredient Purpose

Natural Menthol USP 2.5%................................................................................................ Topical Analgesic

For NDC: 73096-001

For NDC: 73096-001

Active ingredient Purpose

Natural Menthol USP 2%...................................................................................................Topical Analgesic

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

Warnings For external use only Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient on open wounds, damaged irritated skin with a heating pad or TENS device after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes Other information store in a cool place away from direct sunlight store with lid closed tightly If pregnant or breast feeding, ask a health professional before use.

Directions

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

Children under 12 years of age: consult a doctor

Inactive ingredients arnica montana (arnica flower) extract, capsaicin, deionized water, dimethicone, eucalyptus globulus leaf oil, full spectrum hemp extract, glycerin, helianthus

Active ingredient Purpose

Natural Menthol USP 2%................................................................................................... Topical Analgesic

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

NEUROCOMFORT PAIN RELIEF 
pain relief lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4530 mg  in 226.7 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-001-01	226.7 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/27/2019	07/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/27/2019	07/10/2019

NEUROCOMFORT PAIN RELIEF GEL  500
pain relief gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1928 mg  in 96.4 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-002-01	96.4 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/27/2019	07/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/27/2019	07/10/2019

NEUROCOMFORT PAIN RELIEF GEL EXTRA STRENGTH 
pain relief gel extra strength gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2410 mg  in 96.4 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-003-01	96.4 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/27/2019	07/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/27/2019	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(73096-001, 73096-002, 73096-003)

Revised: 7/2019

Document Id: 8decac85-44b7-90d3-e053-2995a90aa63c

34390-5

Set id: 8c53a0bf-2b4b-9337-e053-2995a90a9214

Version: 2

Effective Time: 20190717

 

Harmony Products LLC