MINTED LEAF HEAT THERAPY RELIEF ROLL-ON- capsaicin solution

Minted Leaf Heat Therapy Relief Roll-On by

Drug Labeling and Warnings

Minted Leaf Heat Therapy Relief Roll-On 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:

Capsaicin 0.025%

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:

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) Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Package Labeling:

INGREDIENTS AND APPEARANCE

MINTED LEAF HEAT THERAPY RELIEF ROLL-ON 
capsaicin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73102-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS (UNII: YF70189L0N)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73102-117-03	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)