PAIN RELIEF GEL ROLL ON- menthol gel

Drug Labeling and Warnings

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Warnings

For external use only.

Flammable Keep away from excessive heat or open flames.

Keep out of Reach of Children

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

If Pregnant or breast feeding

If Pregnant or breast feeding as a doctor before use.

Directions

• Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily.
• Children under 2 years of age: ask a doctor
• Wash hands after use with cold water.

Indications and use

Temporarily relieves minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

Other Information

• Store at 20° to 25°C (68° to 77°F)
• Store in cool dry place away from direct sunlight

Inactive Ingredient:

Alcohol, Aloe Vera extract, Arnica Montana Flower extract, Boswellia carteril resin extract, Camellia sinesis leaf extract, Camphor, Carbomer, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex parguariensis leaf extract, Isopropyl myristate, Silica, Triethanolamine, Vitamin E, Water.

Stop Use and Ask Doctor if

Stop use and ask doctor if

• you experience pain, swelling or blistering of the skin
• if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age.

Questions?

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4091-FBA

Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF GEL ROLL ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SILICA (UNII: ETJ7Z6XBU4)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CAMELLIA SINENSIS LEAF OIL (UNII: VC855RRT77)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
FRANKINCENSE (UNII: R9XLF1R1WM)
CARBOMER (UNII: 0A5MM307FC)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-184-01	1 in 1 BOX	04/30/2026
1		0.074 L in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69396-184-03	3 in 1 BOX	04/30/2026
2		0.074 L in 1 BOTTLE; 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	04/27/2026

Labeler - Trifecta Pharmaceuticals USA (079424163)