MYDERM COOLING MENTHOL PAIN RELIEF ROLL-ON WITH 50 PERCENT MORE MENTHOL- menthol gel 
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 Roll-On with 50% More Menthol

Active ingredient

Menthol 4%

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

Uses Temporary relief of pain

For external use only

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

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 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 Roll-On with 50% More Menthol

MYDERM COOLING MENTHOL PAIN RELIEF ROLL-ON WITH 50 PERCENT MORE MENTHOL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72667-022-0174 mL in 1 BOTTLE, PLASTIC; 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(72667-022)

Revised: 1/2023
Document Id: f1ec39f0-2786-2676-e053-2a95a90a5fde
Set id: d4284a1b-dd4f-6bf0-e053-2995a90a6c1e
Version: 10
Effective Time: 20230110
 
Inspec Solutions LLC.