Phizico Pain Relief Cream
FDA Label NDC 85832-621

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Er3 Brands Inc. for the product Phizico Pain Relief (NDC 85832-621). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient(s), purpose, use(s):, warning(s):, do not use, stop use if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient(S)

Menthol 1.00%

Purpose

External Analgesic

Use(S):

For the temporary relief of pain.

Warning(S):

For external use only.

Do Not Use

on damaged or broken skin. Avoid contact with the eyes. Do not bandage tightly.

Stop Use 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.

Direction(S):

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.

Other Ingredients:

Aleurites Moluccanus Seed Oil, Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin, Hedera Helix (lvy) Extract, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Polysorbate 60, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopherol, Triethanolamine, Water (Aqua).

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