MYDERM COOLING MENTHOL PAIN RELIEF WITH 50 PERCENT MORE MENTHOL- menthol spray 
Inspec Solutions LLC

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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myDerm Cooling Menthol Pain Relief Spray with 50% More 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

myDerm Cooling Menthol Pain Relief Spray with 50% More Menthol

MYDERM COOLING MENTHOL PAIN RELIEF WITH 50 PERCENT MORE MENTHOL 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15.75 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FRANKINCENSE (UNII: R9XLF1R1WM)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72667-020-0189 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/27/2021
Labeler - Inspec Solutions LLC (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC.081030372manufacture(72667-020)

Revised: 1/2023
Document Id: f1ec46e5-eeb1-d623-e053-2a95a90a13c3
Set id: d4276749-eeff-28f7-e053-2a95a90a593d
Version: 4
Effective Time: 20230110
 
Inspec Solutions LLC