MINTED LEAF HEAT THERAPY RELIEF ROLL ON- capsaicin liquid
MMG Consumer Brands, 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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MINTED LEAF Heat Therapy Relief Roll-On

Drug Facts

Active ingredient

Capsaicin 0.025%

Purpose

Topical Analgesic

Uses:

For the temporary relief of discomfort and minor aches of muscles and joints associated with strains, bruises and sprains.
Provides rapid cooling relief.

Warnings:

For external use only.

Do not use

On damaged or broken skin.
Do not bandage tightly.
If you are allergic to any ingredients in this product.

When using this product

Keep out of eyes. Rinse with water to remove.
Use only as directed.

Stop use and ask a doctor if

Rash or irritation develops and lasts.
Condition worsens, or if 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.

If pregnant or breastfeeding,

ask a health professional before use. FDA strongly advises against the use of cannabidiol (CBD) in any form during pregnancy or while breastfeeding.

Directions:

Adults: Apply to affected area not more than 3 to 4 times daily.

Inactive 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, Broad Spectrum Hemp Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunfflower) 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.

Other information:

Protect the product in this container from excessive heat and direct sun.
Do not use if seal is broken or missing.

Questions?

9171 S. Dixie Hwy, Pinecrest, FL 33156.

Package Labeling:

Bottle2

MINTED LEAF HEAT THERAPY RELIEF ROLL ON
capsaicin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73102-169
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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 MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS WHOLE (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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73102-169-89	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020	11/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/21/2020	11/30/2022

Labeler - MMG Consumer Brands, LLC (117036455)

Revised: 1/2022

Document Id: d586f908-977a-d5db-e053-2995a90a3a04

Set id: 728c0b4b-91b6-4d18-a9af-8dc1c0feadd0

Version: 3

Effective Time: 20220114

MMG Consumer Brands, LLC