SUNMED Topical Spray with MENTHOL

SUNMED Topical with Menthol by

Drug Labeling and Warnings

SUNMED Topical with Menthol by is a Otc medication manufactured, distributed, or labeled by Sunflora Inc., Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNMED TOPICAL WITH MENTHOL- menthol spray 
Sunflora Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SUNMED Topical Spray with MENTHOL

Active ingredient

Menthol 10.5%

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

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

For external use only

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 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, if swallowed, get medical help or contact a Poison Control Center right away.

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 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

SUNMED TOPICAL WITH MENTHOL 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73240-903
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)
HEMP (UNII: TD1MUT01Q7)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73240-903-01	89 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/30/2022

Labeler - Sunflora Inc. (067153368)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(73240-903)

Revised: 3/2022

Document Id: db6f83c3-c17e-b253-e053-2995a90a5cc2

34390-5

Set id: db6f7da5-aed6-cb18-e053-2995a90abbfc

Version: 3

Effective Time: 20220330