HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 500- menthol usp, 4% gel
HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 500- pain relief gel gel
HARMONY HEMP FLEXIBLE PAIN RELIEF LOTION500- menthol usp, 4% lotion
HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 1000- menthol usp, 4% gel
HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 1000- menthol usp, 4% gel
Abacus Health Products, Inc.

----------

Flexible Pain Relief Line

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

Harmony Hemp

Flexible

Pain Relief Lotion

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

500mg per bottle

Net Wt 8 oz (226.7 g)

Menthol USP, 4%

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

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

For external use only

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.

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

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 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

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

Questions or comments?888-949-4367

For NDC 73096-072 Harmony Hemp Flexible Pain Relief Gel 500

Harmony Hemp

Flexible Pain Relief Gel

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

500mg per bottle

Net Wt 3 oz (85.05 g)

Menthol, USP, 4%

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

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

For external use only

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

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

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

children under 12 years of age: Ask a doctor

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

Questions or comments?888-949-4367

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

Harmony Hemp

Flexible Pain Relief Gel

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

1000mg per bottle

Net Wt 3 oz (85.05 g)

Menthol USP, 4%

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

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

For external use only

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

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

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

children under 12 years of age: Ask a doctor

Questions or comments?888-949-4367

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

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)

Menthol USP, 4%

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

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

For external use only

Do not use

on wounds or damaged skin

When using this product

avoid contact with eyes and mucous membranes
do not bandage tightly or use with a heating pad

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

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

Questions or comments?888-949-4367

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

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)

Menthol USP, 4%

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

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

For external use only

Do not use

on wounds or damaged skin

When using this product

avoid contact with eyes and mucous membranes
do not bandage tightly or use with a heating pad

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

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

Questions or comments?888-949-4367

HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 500
menthol usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73096-074
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2832 mg in 70.8 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)
COTTONSEED OIL (UNII: H3E878020N)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)	500 mg in 70.8 g
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
CLOVE OIL (UNII: 578389D6D0)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
SORBIC ACID (UNII: X045WJ989B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73096-074-02	1 in 1 CARTON	06/26/2019	12/22/2023
1	NDC:73096-074-01	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 Drug	M017	06/26/2019	12/22/2023

HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 500
pain relief gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73096-072
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	3402 mg in 85.05 g

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR, (-)- (UNII: 213N3S8275)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEMP (UNII: TD1MUT01Q7)	500 mg in 85.05 g
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73096-072-02	1 in 1 CARTON	07/10/2019	12/22/2023
1	NDC:73096-072-01	85.05 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	07/10/2019	12/22/2023

HARMONY HEMP FLEXIBLE PAIN RELIEF LOTION500
menthol usp, 4% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73096-071
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	9068 mg in 226.7 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
COTTONSEED OIL (UNII: H3E878020N)
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
WATER (UNII: 059QF0KO0R)
CLOVE OIL (UNII: 578389D6D0)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
SORBIC ACID (UNII: X045WJ989B)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)	500 mg in 226.7 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73096-071-01	226.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/26/2019	12/22/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	06/26/2019	12/22/2023

HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 1000
menthol usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73096-075
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2832 mg in 70.8 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)
COTTONSEED OIL (UNII: H3E878020N)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)	1000 mg in 70.8 g
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
CLOVE OIL (UNII: 578389D6D0)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
SORBIC ACID (UNII: X045WJ989B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73096-075-02	1 in 1 CARTON	06/26/2019	12/22/2023
1	NDC:73096-075-01	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 Drug	M017	06/26/2019	12/22/2023

HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 1000
menthol usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73096-073
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	3402 mg in 85.05 g

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR, (-)- (UNII: 213N3S8275)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEMP (UNII: TD1MUT01Q7)	1000 mg in 85.05 g
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73096-073-02	1 in 1 CARTON	07/10/2019	12/22/2023
1	NDC:73096-073-01	85.05 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	07/10/2019	12/22/2023

Labeler - Abacus Health Products, Inc. (116931574)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions		018950611	manufacture(73096-071, 73096-074, 73096-075)

Name	Address	ID/FEI	Business Operations
Establishment
Inspec Solutions		081030372	manufacture(73096-072, 73096-073)

Revised: 12/2023

Document Id: 0d9a151b-186f-66b2-e063-6294a90ad296

Set id: bc09bfaf-d220-60c6-e053-2a95a90a5dc9

Version: 5

Effective Time: 20231228

Abacus Health Products, Inc.