HARMONY FLEX 10.4% MENTHOL PAIN RELIEF SPREAY 1000MG- menthol spray

Harmony Flex 10.4% Menthol Pain Relief Spreay 1000mg by

Drug Labeling and Warnings

Harmony Flex 10.4% Menthol Pain Relief Spreay 1000mg by is a Otc medication manufactured, distributed, or labeled by Harmony Products LLC., Inspec Solutions LLC,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Menthol 10.4%

PURPOSE

Menthol 10.4% ................. Topical Analgesic

INDICATIONS & USAGE

Uses Temporary relief from minor aches and pains of muscles and joints associated with, arthritis, simple backache, strains, bruises, sprains.

WARNINGS

For external use only

WHEN USING

When using this product, avoid contact with eyes and mucous membranes., do not apply to wound or damage skin, do not bandage, do not use with heating pad or device.

STOP USE

Stop use and ask a doctor if, condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

INACTIVE INGREDIENT

Inactive incredient

Aloe Barbadensis Leaf Extract

Arctium Lappa Root (Burdock) Extract

Arnica Montana Flower Extract

Boswellia Carterii Resin Extract

Calendula Officinalis Extract

Camellia Sinensis Leaf Extract Camphor

Carbomer

FD&C Blue #1

FD&C Yellow #5

Full Spectrum Industrial Hemp Extract

Glycerin

Ilex Paraguariensis (Mate) Leaf Extract

Isopropyl Alcohol

Isopropyl Myristate

Melissa Officinalis (Lemon Balm) Leaf Extract

Silica

Tocopheryl Acetate

Triethanolamine

Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HARMONY FLEX 10.4% MENTHOL PAIN RELIEF SPREAY 1000MG 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
FRANKINCENSE (UNII: R9XLF1R1WM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HEMP (UNII: TD1MUT01Q7)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-048-01	85 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/25/2019

Labeler - Harmony Products LLC. (117041828)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC,		081030372	manufacture(73096-048)