The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Rite Aid Original Strength Vagicaine (NDC 11822-2891). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredient PurposeBenzocaine 5%............................External analgesicResorcinol 2%...............................External analgesic
Otc - Purpose
Active ingredient PurposeBenzocaine 5%.............................External analgesicResorcinol 2%.................................External analgesicUse temporarily relieves itching
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Use temporarily relieves itching
Warnings
Warnings For external use only. When using this product avoid contact with the eyesStop use and ask a doctor if:- condition worsens or if symptoms persist for more than 7 days or clearup and occur again within a few days.Do not apply over large areas of the bodyKeep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions- adults and children 12 years and older apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 or 4 times daily.- children under 12 yearsask a doctorOther informationStore at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
Inactive Ingredient
Inactive Ingredientsaloe barbadebsis leaf extract, carbomer, cetyl alcohol, cholecalciferol, fragrance, glyceryl stearate, Isopropyl myristate, Isopropyl palmitate, Isopropyl stearate, lanolin alcohol, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, purified water, retinyl palmitate, sodium sulfite, tocopheryl acetate, triethanolamine, trisodium HEDTA, zea mays (corn) oil
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