Active Ingredients
Benzocaine 20%
Resorcinol 3%
Feminine Anti Itch Cream
FDA Label NDC 69396-183
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Feminine Anti Itch Cream (NDC 69396-183). 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, otc - keep out of reach of children, indications & usage, directions, inactive ingredients, stop use and ask doctor, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
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.
Indications & Usage
Uses Temporarily relieves itching.
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.
Inactive Ingredients
Inactive ingredient Acrylates (C-10-30)alkyl acrylate crosspolymer, Aloe barbadensis leaf juice, aminomethyl propanol, cetyl alcohol,
Glyceryl stearate, Isopropyl myristate, isopropyl palmitate, lanolin, methylparaben, PEG-100 stearate, Potassium cetyl phosphate, Propylene glycol, Retinyl palmitate, sdium sulfite, tocopheryl acetate, Trisodium HEDTA, vitamin D3, water, Zea mays (corn) oil.
Stop Use And Ask Doctor
Stop Use and ask doctor is condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Other Information
● store at 20° to 25°C ( 68° to 77°F)
.
Warning
For External Use Only
When using avoid contact with eyes.
Otc - Questions
Questions? Call 1-888-296-9067
Other
Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
1-888-296-9067
This product is not manufactured or distributed by Combe Incorporated, owner of the registered trademark Vagasil®
Do Not Use
Do not use this product if youhave a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other caine anesthetics.
* Please review the disclaimer below.
