PAIN RELIEF- menthol spray

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 10.5%

Purpose

Pain Relieving Spray

Indication

Temporary Relief of minor aches and pains of joints and muscles associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For External Use Only

Contents under pressure. Do not puncture or incinerate

Flammable: Keep away from excessive heat or open flame.

Do not store at temperature above 120ºF.

Stop use and ask a doctor

• If you experience pain, swelling or blistering of the skin.
• 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

Keep out of the reach of children

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

Directions

Adults and Children:

12 years of age and older, spray on to affected area not more than 3 to 4 times daily. Massage not necessary.

Children under 12 years of age: consult a physician

wash hands after use with cool water

When using this product

When using this product

• use only as directed
• avoid contact with the eyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if ecessive irritation develops
• do not bandage tightly or use with heating pad or device

Other information

• Store at (20º-25ºC) (68ºF - 77ºF).
• Store in a dry place away from direct sunlight

If Pregnant or breast feeding

Ask a health professional before use.

Inactive Ingredients

Camellia Sinensis leaf extract, centella asiatica extract, Chamomilla recutita (Matricaria) flower extract, Dimethyl sulfone, isopropyl myristate, Glycyrrhiza glabra (licorice) rooth extract, polygonum cuspidatum root extract, Rosmarinus officinais (rosemary) leaf extract, SD alcohol, Scutellaria caicalensis root extract, water.

Questions or Comments

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 6000

* This product is not manufactured or distributed by RB Health (US), the distributor of BioFreeze.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
WATER (UNII: 059QF0KO0R)
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER (UNII: 2788Z9758H)
ROSEMARY (UNII: IJ67X351P9)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-175-03	89 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/25/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/25/2026

Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)