MEDFREEZE NATURALLY COOL PAIN RELIEF- menthol liquid

MedFreeze Naturally Cool Pain Relief by

Drug Labeling and Warnings

MedFreeze Naturally Cool Pain Relief by is a Otc medication manufactured, distributed, or labeled by MEDKO LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Menthol 12%

Purpose

Cooling pain relief

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:  Simple, backache, arthritis, strains, sprains.

Warnings

• For external use only
• Flammable 
• Keep away from excessive heat or open flame 
• Avoid spraying in eyes
• Contents under pressure. Do not puncture or incinerate container. Do not store at temperature above 120°F (48°C)

Do not use

• With heating pad or device 
• With ointments, creams, sprays or liniments 
• On wounds, damaged skin or irritated skin

Ask a doctor before use if you

• Have sensitive skin
• Are pregnant or breastfeeding

When using this product

• Avoid contact with eyes or mucous membranes 
• Do not bandage tightly

Stop use and ask a doctor if

• Condition worsens 
• Symptoms persist for more than 7 days or clear up then reoccur again within a few days  
• Irritation develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Instructions

Adults / Children 2 years and older:

• Spray on the affected area not more than 3 to 4 times daily 
• Shake well before use

Children under 2 years old:Consult a physician.

Other information

• Replace cap after use 
• Store in a cool, dry place

Ingredients

Aqua (deionized water), Calendula officinalis extract, Camellia Sinensis (green tea) extract, Chamomilla Matricaria (chamomile) extract, Citric acid, Echinacea angustifolia extract, Glycerin, Ilex Paraguariensis (Yerba Mate) extract, Berry extract of Juniperus Communis (juniper), Methylsulfonylmethane (MSM), SD-Alcohol 40B.

Questions?

Call 786-956-7146

Package Labelling:

INGREDIENTS AND APPEARANCE

MEDFREEZE NATURALLY COOL PAIN RELIEF 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84443-487
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84443-487-00	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/20/2024

Labeler - MEDKO LLC (130712702)