Active Ingredients
Benzocaine 5%
Benzalkonium Chloride .13%
Vagi-cure Advanced Sensitive Medicated
FDA Label NDC 76466-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sci International, Inc. Dba Continental Pharmaceuticals for the product Vagi-cure Advanced Sensitive Medicated (NDC 76466-011). 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, uses, warnings, otc - stop use, otc - 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 Antiseptic
Uses
- Temporarily relieves itching
Warnings
For external use only
Avoid contact with 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.
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
adult and children 2 years and older
apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.
children under 2 years
consult a doctor
Inactive Ingredients
Aloe Vera Gel, Carbomer, Cetyl Alcohol, De-ionized Water, Disodium EDTA, Fragrance, Glycerol Monostearate, Isopropyl Myristate, Isopropyl Palmitate, Lanolin Anhydrous, Methylparaben, Mineral Oil, Peg 100 Stearate, Propylene Glycol, Propylparaben, Vitamin E (Tocopheryl Acetate).
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
Vagi-Cure
Anti-Itch Cream
Advance Sensitive Medicated Cream
NET WT 0.75oz (21g)
Label Of Vagi-cure Advance (Vagi Cure Advance)
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