4% MENTHOL COLD THERAPY- menthol gel

4% MENTHOL COLD THERAPY by

Drug Labeling and Warnings

4% MENTHOL COLD THERAPY by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains provides cooling pain relief

Warnings

For external use only

When using this product
avoid contact with eyes  do not apply to wounds or damaged skin 
do not bandage tightly  do not use with heating pads or heating devices

Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable: Keep away from excessive heat or open flame

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: do not use, consult a doctor
wash hands after use with cool water

Other information

store in a cool dry place away from direct sunlight  store with cap closed tightly

Inactive ingredients

Arnica Montana Flower Extract, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arctium Lappa Extract, Butylene Glycol, Boswellia Serrata Resin Extract, Camphor, Carbomer, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, FD&C Blue No.1, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water, Yellow No.5

SPL UNCLASSIFIED SECTION

Compare to Biofreeze® Menthol Pain Relieving Gel active ingredient

Cooling Pain Relief | Menthol Topical Analgesic

For Minor Aches & Muscle Pain

COOLING MENTHOL FORMULA

For Arthritis Backache
Joint & Muscle Pain
Fast-Acting and Long-Lasting

Mfd for and Distributed by:
Universal Distribution Center LLC
330 Applegarth Road,
Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Packaging

INGREDIENTS AND APPEARANCE

4% MENTHOL COLD THERAPY 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-442
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-442-15	1 in 1 BOX	01/19/2026
1		42.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/19/2026

Labeler - Universal Distribution Center LLC (019180459)