HARMONY HEMP FLEXIBLE 4% MENTHOL PAIN RELIEF CREAM-GEL 1000MG- menthol lotion

Harmony Hemp Flexible 4% Menthol Pain Relief Cream-Gel 1000mg by

Drug Labeling and Warnings

Harmony Hemp Flexible 4% Menthol Pain Relief Cream-Gel 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 4%

PURPOSE

Menthol 4% ........... Topical analgesic

INDICATIONS & USAGE

Uses Temporary relief of pain

WARNINGS

For external use only

WHEN USING

DO not use in large quantities over raw surfaces and blistered area

When using this product

Use only as directed, read and follow all directions and warnings on this label, rare cases of serious burn have been reported with product of this type, do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with medicated patch, avoid contact with eyes and mucous membranes

STOP USE

Stop use and ask doctor if, condition worsens, redness is present, irritation develops, 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 ingredients

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 HEMP FLEXIBLE 4% MENTHOL PAIN RELIEF CREAM-GEL 1000MG 
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-057-01	85.05 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/29/2020

Labeler - Harmony Products LLC. (117041828)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(73096-057)