MINTED LEAF Cold Therapy Relief Gel

MINTED LEAF Cold Therapy Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

MINTED LEAF COLD THERAPY RELIEF- menthol gel 
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 Cold Therapy Relief Gel

Drug Facts

Active ingredient

Menthol 4%

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.
• Wash hands after use.

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:

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, Broad Spectrum Hemp Oil, 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.

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:

MINTED LEAF COLD THERAPY RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73102-168
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
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN (UNII: 0N8672707O)
PROPANEDIOL (UNII: 5965N8W85T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73102-168-89	89 mL in 1 TUBE; Type 0: Not a Combination Product	07/21/2020	07/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/21/2020	07/31/2021

Labeler - MMG Consumer Brands, LLC (117036455)

Revised: 1/2022

Document Id: d586ee6b-5230-c849-e053-2a95a90a3654

34390-5

Set id: 38edc6c6-e279-4c52-a871-634eefb9362f

Version: 3

Effective Time: 20220114