PT ELITE PREMIUM PAIN RELIEF- capsaicin, menthol cream

PT Elite Premium Pain Relief by

Drug Labeling and Warnings

PT Elite Premium Pain Relief by is a Otc medication manufactured, distributed, or labeled by PT ELITE PRODUCTS LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Capsaicin 0.035%
Menthol 4.000 %

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.

Warnings

For external use only

Do not use

• on damaged or broken skin.

When using this product

• Avoid contact with the eyes. 
• Do not bandage tightly.

Stop use and ask a doctor if

• rash or irritation develops and lasts. 
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

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: consult a doctor.

Other information:

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Boswellia Serrata Extract, Butylene Glycol, Caprylic/Capric Triglyceride, Ceteareth-20, Cetyl Alcohol, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate SE, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ilex Paraguariensis Leaf Extract, Mineral Oil (Paraffinum Liquidum), Phenoxyethanol, Polysorbate 20, Polysorbate 60, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Squalane, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Storage

For best results, store at 68-77F (20-25 C) in dry place.

Questions or Comments

702-665-4054

Package Labeling:

INGREDIENTS AND APPEARANCE

PT ELITE PREMIUM PAIN RELIEF 
capsaicin, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85808-615
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.35 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARETH-20 (UNII: YRC528SWUY)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALMOND OIL (UNII: 66YXD4DKO9)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85808-615-00	1 in 1 BOX	05/09/2025
1		100 mL 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	05/09/2025

Labeler - PT ELITE PRODUCTS LLC (137168015)

Registrant - Pure Source, LLC (080354456)