MINTED LEAF COLD THERAPY PAIN RELIEF- menthol gel

Minted Leaf Cold Therapy Pain Relief by

Drug Labeling and Warnings

Minted Leaf Cold Therapy Pain Relief by is a Otc medication manufactured, distributed, or labeled by MMG Consumer Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient:

Menthol 4.00%

Purpose

Topical Analgesic

Indications:

• For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis
• simple backache
• sprains
• bruises and strains.

Warnings:

• For external use only.
• Avoid contact with eyes.
• If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

• If swallowed, consult physician.

Do not apply

• to wounds or damaged skin.
• Do not bandage tightly.

If pregnant or breast feeding,

• contact physician prior to use.

Directions:

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
• Children under two-years of age: consult a physcian.

Additional Information:

Store at room temperature.

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arcticum Lappa (Burdock) Root Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Cannabis Sativa (Broad Spectrum Hemp), Copper Sulfate, Ethylhexylglycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Package Labeling:

INGREDIENTS AND APPEARANCE

MINTED LEAF COLD THERAPY PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73102-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS (UNII: YF70189L0N)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73102-115-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2019

Labeler - MMG Consumer Brands, LLC (117036455)