Otc - Active Ingredient
Active ingredients PurposeBenzocaine 20%....................External AnalgesicResorcinol 3%........................External Analgesic
Benzocaine And Resorcinol
FDA Label NDC 55910-185
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc for the product Benzocaine And Resorcinol (NDC 55910-185). 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
Use temporarily relieves itching
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
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 persist for more than 7 days or clear up and occur again within a few days_______________________________________________________________________________________________________________________Do not apply over large areas of the bodyKeep out of 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 to 4 times daily children under 12 years ask a doctor
Inactive Ingredient
Inactive Ingredients aloe barbadensis leaf extract, carbomer 940, cetyl alcohol, cholecalciferol, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin alcohol, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, purified water, retinyl palmitate, sodium sulfite, tocopheryl acetate, trisodium HEDTA, trolamine, zea mays (corn) oil
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