HARMONY FLEXIBLE 4% MENTHOL PAIN RELIEF ROLL-ON 1000MG- menthol cream

Harmony Flexible 4% Menthol Pain Relief Roll-On 1000mg by

Drug Labeling and Warnings

Harmony Flexible 4% Menthol Pain Relief Roll-On 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

Menthol 4%

PURPOSE

Menthol 4% ...............Topical Analgesic

INDICATIONS & USAGE

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

WARNINGS

For external use only

WHEN USING

When using this product

Use only as directed, do not bandage tightly or use with 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

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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 FLEXIBLE 4% MENTHOL PAIN RELIEF ROLL-ON 1000MG 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-044
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAMPHOR OIL (UNII: 75IZZ8Y727)
HEMP (UNII: TD1MUT01Q7)
FRANKINCENSE (UNII: R9XLF1R1WM)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-044-01	70.8 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2019
2	NDC: 73096-044-02	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/24/2019

Labeler - Harmony Products LLC. (117041828)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(73096-044)