Pt Elite Premium Pain Relief Cream

Pt Elite Premium Pain Relief Cream
SPL v2
SPL
SPL Set ID ad251821-4c58-425d-bdcb-8dd9bd41b713
Route
TOPICAL
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.35 mg) Menthol (40 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Juice Arnica Montana Whole Indian Frankincense Butylene Glycol Medium-chain Triglycerides Ceteareth-20 Cetyl Alcohol Dimethyl Sulfone Ethylhexylglycerin Eucalyptus Oil Glycerin Glyceryl Stearate Se Phenoxyethanol Polysorbate 20 Polysorbate 60 Almond Oil Squalane Stearic Acid .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-09
Description

Capsaicin 0.035% Menthol 4.000 %

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.035% Menthol 4.000 %

Uses
  • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Storage

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

Warnings

For external use only

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.
Do Not Use
  • on damaged or broken skin.
Drug Facts

Package Labeling:

Active Ingredients

Capsaicin 0.035%

Menthol 4.000 %

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)

Questions Or Comments

702-665-4054

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.
If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

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

Structured Label Content

Uses
  • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Purpose

Topical Analgesic

Storage

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

Warnings

For external use only

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.
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Package Labeling:

Active Ingredients

Capsaicin 0.035%

Menthol 4.000 %

Other Information: (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)

Questions Or Comments (Questions or Comments)

702-665-4054

When Using This Product (When using this product)
  • Avoid contact with the eyes. 
  • Do not bandage tightly.
Stop Use and Ask A Doctor If (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.
If Pregnant Or Breast Feeding, (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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:36.838453 · Updated: 2026-03-14T23:09:29.869893