Thera Plus Maximum Strength Feminine Anti-itch Cream
FDA Label NDC 80684-142
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Thera Plus Maximum Strength Feminine Anti-itch (NDC 80684-142). 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 drug facts, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor, 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
Active Ingredients
Benzocaine 20%
Resorcinol 3%
Purpose
External Analgesic
Uses
temporarily relieves itching
Warnings
For external use only.
When Using This Product
avoid contact with the eyes.
Stop Use And Ask A Doctor
if condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days.
Do not applyover 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 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 Ingredientsa
aloe barbadensis leaf juice, cetyl alcohol, cholecalciferol, edetate disodium, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, lanolin, methylparaben, mineral oil, petrolatum, propylene glycol, retinol, sodium lauryl sulfate, sodium sulfite, tocopherol, water
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