Otc - Active Ingredient
Active ingredients PurposeBenzocaine 20%....................External AnalgesicResorcinol 3%........................External Analgesic
Benzocaine And Resorcinol
FDA Label NDC 59779-810
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Benzocaine And Resorcinol (NDC 59779-810). 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.
Label Section Quick Index
Otc - Purpose
Usetemporarily relieves itching
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contacta Poison Control Center right away.
Indications & Usage
Use temporarily relieves itchingOther information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)
Warnings
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 persistfor more than 7 days or clear up and occur again within a few days_______________________________________________________________Do not apply over large areas of the body_______________________________________________________________
Dosage & Administration
Directions adults and apply a fingertip amount (approximately children 12 years 1 inch strip) to the affected area not and older more than 3 to 4 times daily _______________________________________________________ children under 12 years ask a doctor
Inactive Ingredient
Inactive Ingredients aloe barbadensis leaf extract, carbomer, cetylalcohol, cholecalciferol, fragrance, glyceryl stearate, isopropyl myristate, isopropylpalmitate, isopropyl stearate, lanolin alcohol, methylparaben, mineral oil, PEG-100stearate, propylene glycol, purified water, retinyl palmitate, sodium sulfite, tocopherylacetate, trisodium HEDTA, triethanolamine, zea mays (corn) oil
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