Harmony Hemp Flexible Pain Relief Gel 1000

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
4
Source
legacy-cache
Hydrated at
2026-08-01 22:50:16

Label at a glance#

ProductHarmony Hemp Flexible Pain Relief Roll-on 500
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure6 sections

Label contents#

Full prescribing information#

RECENT MAJOR CHANGES SECTION

Uses and Directions for each product NDC

For NDC 73096-071 Harmony Hemp Flexible Pain Relief Lotion 500

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp

Flexible

Pain Relief Lotion

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

500mg per bottle

Net Wt 8 oz (226.7 g)

OTC - ACTIVE INGREDIENT SECTION

Menthol USP, 4%

OTC - PURPOSE SECTION

Menthol USP, 4%.....................Topical analgesic

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight.
OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • condition worsens
  • blistering or burning occurs
  • pain or swelling occurs
  • symptoms persist for more than 7 days or 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 generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily

children under 12 years of age: Ask a doctor

INACTIVE INGREDIENT SECTION

beeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil, 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 73096-072 Harmony Hemp Flexible Pain Relief Gel 500

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp

Flexible Pain Relief Gel

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

500mg per bottle

Net Wt 3 oz (85.05 g)

OTC - ACTIVE INGREDIENT SECTION

Menthol, USP, 4%

OTC - PURPOSE SECTION

Menthol, USP, 4%................................Topical analgesic

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken, or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight
OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • condition worsens
  • blistering or burning occurs
  • pain or swelling occurs
  • symptoms persist for more than 7 days or 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

children under 12 years of age: Ask a doctor

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hemp extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica, tocopheryl acetate, triethanolamine, yellow 5, water

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

SPL UNCLASSIFIED SECTION

22

33

For NDC 73096-073 Harmony Hemp Flexible Pain Relief Gel 1000

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp

Flexible Pain Relief Gel

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

1000mg per bottle

Net Wt 3 oz (85.05 g)

OTC - ACTIVE INGREDIENT SECTION

Menthol USP, 4%

OTC - PURPOSE SECTION

Menthol USP, 4%...........................Topical analgesic

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken, or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight
OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • condition worsens
  • blistering or burning occurs
  • pain or swelling occurs
  • symptoms persist for more than 7 days or 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

children under 12 years of age: Ask a doctor

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hemp extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica, tocopheryl acetate, triethanolamine, yellow 5, water

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

SPL UNCLASSIFIED SECTION

aa

ss

For NDC 73096-074 Harmony Hemp Flexible Pain Relief Roll-on 500

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp

Flexible

Pain Relief Roll-on

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

500mg per bottle

Net Wt 2.5 oz (70.8 g)

OTC - ACTIVE INGREDIENT SECTION

Menthol USP, 4%

OTC - PURPOSE SECTION

Menthol USP, 4%......................Topical analgesic

INDICATIONS & USAGE SECTION

temporary relief of minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes and mucous membranes
  • do not bandage tightly or use with a heating pad
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
  • excessive skin irritation develops
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

beeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid, water

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

SPL UNCLASSIFIED SECTION

qq

ww

For NDC 73096-075 Harmony Hemp Flexible Pain Relief Roll-on 1000

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp

Flexible

Pain Relief Roll-on

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

1000mg per bottle

Net Wt 2.5 oz (70.8 g)

OTC - ACTIVE INGREDIENT SECTION

Menthol USP, 4%

OTC - PURPOSE SECTION

Menthol USP, 4%......................Topical analgesic

INDICATIONS & USAGE SECTION

temporary relief of minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

WARNINGS SECTION

​For external use only

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes and mucous membranes
  • do not bandage tightly or use with a heating pad
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
  • excessive skin irritation develops
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

beeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid, water

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

SPL UNCLASSIFIED SECTION

zz

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d9a151b-186f-66b2-e063-6294a90ad296bc09bfaf-d220-60c6-e053-2a95a90a5dc92023-12-28WarningsExact identifier
spl set id: bc09bfaf-d220-60c6-e053-2a95a90a5dc9

Reported adverse events (FAERS/openFDA)#

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