The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Capsaicin (NDC 59779-622). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredient PurposeCapsaicin 0.1%............................................Topical analgesic
Otc - Purpose
Uses for the temporary relieves of minor aches and pains of muscles and joints associated with:- arthritis - simple backache - strains - bruises
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If case of overdose or allergic reaction, seek medical attention or contacta Poison Control Center right away.
Indications & Usage
Uses for the temporary relieves of minor aches and pains of muscles and joints associated with:
- arthritis - simple backache - strains - bruises
Warnings
Warnings For external use onlyWhen using this product- use only as directed - do not apply to wounds, damaged, broken or irritated skin - avoid contactwith the eyes or mucous membranes - a slight burning sensation may occur upon application, butgenerally disappears in several days - if severe burning occurs, discontinue use - do not exposethe treated area to heat or direct sunlight - do not bandage - do not use with heating padStop use and consult a dentist or doctor if: - condition worsens - symptoms persist for more than 7 days or clear up and occur again within a few days- redness is present - irritation develops Keep out of the reach of children.In case of overdose or allergic reaction, seek medical attention or contact a Poison Control Center right away.If pregnant or breast feeding, ask a health professional before use.
Dosage & Administration
Directions Adults and children over 18 years- apply to affected area- Massage into the painful area until thoroughly absorbed- Repeat as necessary, but no more than 3 to 4 times daily- WASH HANDS WITH SOAP AND WATER AFTER APPLYINGChildren 18 years and younger: ask a doctor.
Inactive Ingredient
Inactive Ingredientspurified water, petrolatum, cetyl alcohol glyceryl stearate, PEG-40 stearate, isopropyl myristate, sorbitol, PEG-2 stearate, benzyl alcohol
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