MYDERM PRO FREEZE COOLING MENTHOL PAIN RELIEF ROLL-ON- menthol gel

MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On by

Drug Labeling and Warnings

MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Menthol 6%

WHEN USING

When using this product avoid contacts with the eyes or mucous membranes. do not apply to wounds or damaged skin. do not apply to irritated skin. do not bandage. wash hands after use with cool water. do not use with heating pad or device.

PURPOSE

Menthol 6%------------------------------------------------------------Topical Analgesic

WARNINGS

For external use only.

STOP USE

Stop use and ask doctor if condition worsens, or if symtoms persist for more than 7 days, or clean up and reoccur again within a few days.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children if swallowed,get medical help or contact a poson Control Center Immediately.

INACTIVE INGREDIENT

Inactive Ingredient

Aloe Barbadensis Leaf Juice

Arctium Lappa Root 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

Glycerin

Isopropyl Alcohol

Isopropyl Myristate

llex Paraguariensis Leaf Extract

Melissa Officinalis Leaf Extract

Phenoxyethanol

Silicon dioxide

Tocopheryl Acetate

Triethanolamine

Water

DOSAGE & ADMINISTRATION

Direction: Apply to affectered area not more that 3 to 4 times daily.

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYDERM PRO FREEZE COOLING MENTHOL PAIN RELIEF ROLL-ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR, (-)- (UNII: 213N3S8275)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
FRANKINCENSE (UNII: R9XLF1R1WM)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-073-01	89 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/06/2024

Labeler - Inspec Solutions (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(72667-073)