FDA.reportPublic FDA data

Harmony Hemp NeuroComfort Pain Relief Gel 500

Manufacturer
Abacus Health Products, Inc. | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | Inspec Solutions
Effective date
2021-02-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:50:15

Label at a glance#

ProductHarmony Hemp NeuroComfort Pain Relief Lotion500
Active ingredientLIDOCAINE
Label structure6 sections

Label contents#

Full prescribing information#

RECENT MAJOR CHANGES SECTION

For all products:

Uses: temporary relief of pain; temporarily relieves pain

Directions

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

For NDC 73096-065 Harmony Hemp NeuroComfort Pain Relief Lotion 500

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp

NeuroComfort

Pain Relief Lotion

Lidocaine HCL 4%

Hands & Feet

CBD Moisturizing Oil

500mg per bottle

Net Wt 8 oz (226.7 g)

OTC - ACTIVE INGREDIENT SECTION

LIdocaine HCL USP, 4%

OTC - PURPOSE SECTION

LIdocaine HCL USP, 4%.................Topical analgesic

INDICATIONS & USAGE SECTION

temporary relief of pain

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces and blistered areas

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes and mucous membranes
OTC - STOP USE SECTION

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
OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use if pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

beeswax, CBD hemp oil, cottonseed oil, emulsifying wax, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid, water

SPL UNCLASSIFIED SECTION

11

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

For NDC 73096-066 Harmony Hemp NeuroComfort Pain Relief Gel 500

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp

NeuroComfort

Pain Relief Gel

Lidocaine HCL 4%

Hands & Feet

CBD Moisturizing Oil

500mg per bottle

Net Wt 3 oz (85.05g)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL USP, 4%

OTC - PURPOSE SECTION

Lidocaine HCL USP, 4%...................Topical anesthetic

INDICATIONS & USAGE SECTION

temporary relief of pain

WARNINGS SECTION

Warnings: For external use only

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces and blistered areas

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes and mucous membranes
OTC - ASK DOCTOR SECTION

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
OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use if pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

SPL UNCLASSIFIED SECTION

22

33

For NDC 73096-067 Harmony Hemp NeuroComfort Pain Relief Gel 1000

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp

NeuroComfort

Pain Relief Gel

Lidocaine HCL 4%

Hands & Feet

CBD Moisturizing Oil

1000mg per bottle

Net wt 3 oz (85.05 g)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL USP, 4%

OTC - PURPOSE SECTION

Lidocaine HCL USP, 4%.......................Topical anesthetic

INDICATIONS & USAGE SECTION

temporary relief of pain

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces and blistered areas

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes and mucous membranes
OTC - ASK DOCTOR SECTION

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
OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use if pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

SPL UNCLASSIFIED SECTION

44

55

For NDC 73096-068 Harmony Hemp NeuroComfort Pain Relief Roll-on 500

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL, 4%

OTC - PURPOSE SECTION

Lidocaine HCL, 4%....................Topical anesthetic

INDICATIONS & USAGE SECTION

temporarily relieves pain

WARNINGS SECTION

Warnings: For external use only

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces and blistered areas

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes and mucous membranes
OTC - ASK DOCTOR SECTION

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
OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use if pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

SPL UNCLASSIFIED SECTION

aa

bb

For NDC 73096-069 Harmony Hemp NeuroComfort Pain Relief Roll-on 1000

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL, 4%

OTC - PURPOSE SECTION

Lidocaine HCL, 4%........................Topical anesthetic

INDICATIONS & USAGE SECTION

temporarily relieves pain

WARNINGS SECTION

Warnings: For external use only

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces and blistered areas

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes and mucous membranes
OTC - ASK DOCTOR SECTION

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
OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use if pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center immediately.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

SPL UNCLASSIFIED SECTION

rr

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73096-06573096-065-01
73096-06673096-066-01, 73096-066-02
73096-06773096-067-01, 73096-067-02
73096-06873096-068-01, 73096-068-02
73096-06973096-069-01, 73096-069-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 81 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLAWAX POLYSORBATEQ504PL8E0VIACT
SHEA BUTTERK49155WL9YIACT
SORBIC ACIDX045WJ989BIACT
LIDOCAINE98PI200987ACTIB
YELLOW WAX2ZA36H0S2VIACT
WATER059QF0KO0RIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
COTTONSEED OILH3E878020NIACT
JOJOBA OIL724GKU717MIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
STEARETH-2153J3F32P58IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
C30-45 ALKYL METHICONENFX970DSI2IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20 PHOSPHATE921FTA1500IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE92RU3N3Y1OIACT
HEMPTD1MUT01Q7IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
STEARETH-2153J3F32P58IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
C30-45 ALKYL METHICONENFX970DSI2IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20 PHOSPHATE921FTA1500IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d99e316-e5fc-fe8e-e063-6294a90a6a0ebc03a3d8-fdb6-15d3-e053-2995a90a88322023-12-28WarningsExact identifier
spl set id: bc03a3d8-fdb6-15d3-e053-2995a90a8832

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.