HOT/COLD MENTHOL 16% ROLL-ON liquid

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 16%

PURPOSE

Topical analgesic

INDICATIONS & USAGE

Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.

WARNINGS

For external use only.

Flammable

• Keep away from fire or flame.

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• a temporary burning sensation may occur after use but normally disappears in several days
• if severe burning sensation occurs, discontinue use immediately
• if swelling or blistering of the skin occurs, stop use and seek medical attention
• do not expose treated area to heat or direct sunlight

Stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Children 12 years or younger: do not use, ask a doctor

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, Purified Water, SD Alcohol 40 (30%), Triethanolamine.

QUESTIONS

1-833-551-0932

2026 Label

INGREDIENTS AND APPEARANCE

HOT/COLD MENTHOL 16% ROLL-ON 
hot/cold menthol 16% roll-on liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
CAPSAICIN (UNII: S07O44R1ZM)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82645-014-97	1 in 1 CARTON	04/14/2026
1		74 mL in 1 BOTTLE, WITH APPLICATOR; 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	04/14/2026

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	label(82645-014) , pack(82645-014) , analysis(82645-014) , manufacture(82645-014)