Active Ingredient
Capsicum Oleoresin (Containing Capsaicin 0.025%)
Penetral Roll-on Gel
FDA Label NDC 59088-329
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Penetral Roll-on (NDC 59088-329). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor 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
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.
■ Provides warming pain relief.
Warnings
For external use only
Do Not Use
■ on wounds or damaged skin
■ with a heating pad or any source of heat
■ if you are allergic to capsicum or any ingredients of this product
■ do not bandage tightly
When Using This Product
■ avoid contact with eyes and other mucous membranes.
■ do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise.
Stop Use And Ask A Doctor If
■ condition worsens, or if symptoms persist for more than 7 days or clears up and occurs again within a few days, discontinue use of this product and consult a doctor.
■ redness is present ■ irritation develops
Keep Out Of Reach Of Children.
■ if pregnant or breast-feeding, ask a doctor before use.
■ if swallowed, get medical help or contact Poison Control Center right away.
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: do not use, consult a doctor
■ Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
Other Information
■ store at controlled room temperature 20° to 25°C (68° to 77°F) ■ store in a clean, dry place away from sunlight ■ protect from freezing ■ avoid excessive heat
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Glycerin, Hydrolyzed Corn Starch Octenylsuccinate, Lauryl Laurate, Linum Usitatissimum (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica, Sodium Hydroxide, Water.
Package Label.Principal Display Panel
Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
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1-877-921-7873
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