Harmony Hemp Flexible Pain Relief Spray 500

Drug Details [pdf]

HARMONY HEMP FLEXIBLE PAIN RELIEF SPRAY500- menthol usp, 10.5% spray
Abacus Health Products, Inc.

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Harmony Hemp Flexible Pain Relief Spray 500

Menthol USP, 10.5%

Menthol USP, 10.5% ................. 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

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 occur again within a few days

Flammable:keep away from excessive heat or open flame

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 over 12 years of age:

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 12 years of age or younger: Ask a doctor.

alcohol denat., arnica montana flower extract, calendula officianalis flower extract, camellia sinensis leaf extract, chamomile recutita flower extract, dimethyl sulfone, echinacea angustifolia extract, ilex paraguariensis leaf extract, industrial hemp extract, isopropyl myristate, juniperus communis fruit extract, water

Questions or comments?888-949-4367

HARMONY HEMP FLEXIBLE PAIN RELIEF SPRAY500
menthol usp, 10.5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-076
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8925 mg in 85 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
HEMP (UNII: TD1MUT01Q7)	500 mg in 85 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
JUNIPER BERRY (UNII: O84B5194RL)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 73096-076-01	85 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/25/2019	12/22/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	10/25/2019	12/22/2023

Labeler - Abacus Health Products, Inc. (116931574)

Name	Address	ID/FEI	Business Operations
Establishment
Inspec Solutions		081030372	manufacture(73096-076)

Revised: 12/2023

Document Id: 0d9a2510-81aa-6dfe-e063-6294a90acafc

Set id: bc0b2e7e-9c8e-30cf-e053-2a95a90ac198

Version: 4

Effective Time: 20231228

Harmony Hemp Flexible Pain Relief Spray 500

Harmony Hemp Flexible Pain Relief Spray500 by

Drug Labeling and Warnings

Drug Details [pdf]

Harmony Hemp Flexible Pain Relief Spray 500