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 Spray with MENTHOL

SUNMED TOPICAL WITH MENTHOL 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73240-903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73240-903-0189 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/30/2022
Labeler - Sunflora Inc. (067153368)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC.081030372manufacture(73240-903)

Revised: 3/2022
Document Id: db6f83c3-c17e-b253-e053-2995a90a5cc2
Set id: db6f7da5-aed6-cb18-e053-2995a90abbfc
Version: 3
Effective Time: 20220330
 
Sunflora Inc.