Otc - Active Ingredient
Active Ingredient: Capsaicin 0.1%
Capzix Cream
FDA Label NDC 72847-316
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Toprail Chp Llc. for the product Capzix (NDC 72847-316). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Topical Analgesic
Indications & Usage
Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings
Warnings: For external use only. Avoid contact with eyes.
Do not apply to wounds or damaged skin. Do not bandage tightly or apply local heat (such as heating pads) to the area of use. Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions – Adults and children over 18
Apply to affected area not more than 3 to 4 times daily.
If product comes in contact with hands, wash with soap and water.
For children under 18 years of age ask a doctor.
Storage And Handling
Other Information: STORE TIGHTLY CLOSED, IN A COOL DRY PLACE
Inactive Ingredient
Inactive Ingredients: Water, Cetyl Alcohol, Petrolatum, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Isopropyl Myristate, Benzyl Alcohol, Citric Acid.
Packaging
Label (Label 1)
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