PAIN RELIEF GEL-ROLL ON- menthol gel

Drug Labeling and Warnings

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Lidocaine 4%

Purpose

Topical Analgesic

Active Ingredient

Menthol 1%

Purpose

Topical Analgesic

Warnings

For external use only.

Flammable Keep away from excessive heat or flame.

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 over 12 years: apply to the affected area not more than 3 to 4 times daily.
• Children 12 years or younger: ask a doctor
• After applying wash hands with soap and water

Indications and use

Temporarily relieves minor pain.

Other Information

• Store at 20° to 25°C (68° to 77°F)

Inactive Ingredient:

Aloe Vera Extract, Carbomer, Isopropyl Myristate, Lavender oil, Phenoxyethanol, Polysorbate 80, Propylene glycol, Tartaric Acid, Vitamin E, Water

Stop Use and Ask Doctor if

Stop use and ask doctor if

• Condition worsens
• severe burning sensation, redness, rash or irritation deveolps
• symptoms persisit for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury such as pain, swelling or blistering where the product was applied.

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: 4092-FBA

PRINCIPAL DISPLAY PANEL

Label

INGREDIENTS AND APPEARANCE

PAIN RELIEF GEL-ROLL ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 g  in 1 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
TARTARIC ACID (UNII: W4888I119H)
LAVENDER OIL (UNII: ZBP1YXW0H8)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
CARBOMER (UNII: 0A5MM307FC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-185-01	1 in 1 BOX	04/30/2026
1		0.073 L in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69396-185-03	3 in 1 BOX	04/30/2026
2		0.073 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)