Active Ingredient
Benzocaine 5%
Benzalkonium Chloride .13%
Assured
FDA Label NDC 33992-2013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International for the product Assured (NDC 33992-2013). 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 ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Uses
▪ temporarily relieves itching
Warnings
For external use only
Avoid contact with 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 body
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away
Directions
Adults and children 2 years of age and older: Apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor
Inactive Ingredients
Purified water, Peg-400, Cetearyl Alcohol, Paraffinum Liquidum, Hydroxpropyl Bisstearyldimonium Chloride, Dimethicone, Glyceryl Stearate & Peg-100 Stearate, Diaziolidinyl Urea, Methyparaben, Propylparaben
Package Label
Package Label (Assrdfemantiitch)
* Please review the disclaimer below.
