Active Ingredient
Benzocaine 20%
Resorcinol 3%
Vagisil Anti-itch Medicated Creme Maximum Strength Cream
FDA Label NDC 11509-4402
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Combe Incorporated for the product Vagisil Anti-itch Medicated Creme Maximum Strength (NDC 11509-4402). 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, use, warnings, stop use and ask doctor if, keep out of reach of children., directions, inactive ingredients, 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
Use
temporarily relieves itching
Warnings
For external use only
Avoid contact with eyes
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
Do not apply over large areas of the body
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 (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses. |
| children under 12 years | consult a doctor |
Inactive Ingredients
Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium HEDTA, Maltodextrin
Principal Display Panel
Vagisil®
Maximum Strength
Anti-Itch crème
Net Wt. 1 oz. (28 g)
Vagisil®maximum Strengthanti-itch Crèmenet Wt. 1 Oz. (28 G) (Vagisil Anti Itch Medicated Creme 01)
* Please review the disclaimer below.
