Active Ingredients
Benzocaine 20%
Resorcinol 3%
Vagicaine Maximum Strength Anti-itch Cream
FDA Label NDC 59779-588
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 Pharmacy for the product Vagicaine Maximum Strength Anti-itch Cream (NDC 59779-588). 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 ingredients, purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, otc - 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
External Analgesic
External Analgesic
Indications & Usage
Temporarily relieves itching
Warnings
For external use only
Otc - When Using
When using this product avoid contact with the eyes
Otc - Stop 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.
Otc - Do Not Use
Do not apply over large areas of the body
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
| adults and children 12 years and older | apply a fingertip amount (appriximately 1-inch strip) to the affected area not more than 3 to 4 times daily |
| children under 12 years | ask a doctor |
Other Information
- store at 20°-25°C (68° - 77°F)
Inactive Ingredients
Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, PEG-100 Stearate and Glyceryl Monostearate, PEG-40 Hydrogenated Castor Oil, Isopropyl Palmitate, Carbomer, Triethanolamine, Methylparaben, Tocopheryl Acetate, Hydroxyethylcelluse, Xanthan Gum, Maltodextrin, Propylparaben, Disodium EDTA, Aloe Barbadensis (Alow Vera) Leaf Extract, Fragrance
Package Label.Principal Display Panel
Maximum Strength
Vagicaine
Medicated anti-itch cream
Net Wt 1 oz (28g)
CVS Health TM Maximum Strength Vagicaine Medicaided Anti-Itch Cream provides instant relief from painful, burning itch using the power of benzocaine and resorcinol combined with the soothing vitamin E plus aloe.
*This product is not manufactured or distributed by Combe Inc., owner of the registered trademark Vagisil TM maximum Strength Anti-Itch Cream
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02995
(c) 2016 CVS/pharmacy
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