Otc - Active Ingredient
Capsaicin 0.1%
Cvs Roll-on Gel
FDA Label NDC 51316-265
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cvs Roll-on (NDC 51316-265). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
Temporarily relieves minor pain associated with arthritis, simple backache, sprains, bruises, muscle strains, and cramps.
Warnings
For external use only.
When using this product do not bandage tightly or cover treated area, do not use with heating pad, avoid contact with eyes and mucous membranes, do not apply to wounds, damaged, broken or irritated skin, a transient burning sensation may occur upon application but generally disappears in several days, if severe burning occurs, discontinue use immediately, do not expose the area treated with product to heat or direct sunlight.
Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, redness is present, or irritation develops.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children of 18 years: apply to affected area, massage into painful area until thoroughly absorbed, repeat as necessary, but no more than 3 to 4 times daily. WASH HANDS WITH SOAP AND WATER AFTER APPLYING. Children 18 years or younger: ask a doctor.
Inactive Ingredient
Alcohol denat., aminomethyl propanol, carbomer, glycerin, propylene glycol, water.
Package Label.Principal Display Panel
Label (Cvs Capsaicin Rollon Ifc Outside Cvs Capr1 25 Print)
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