Otc - Active Ingredient
Benzocaine 20%
Benzocaine Gel
FDA Label NDC 71888-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bellus Medical, Llc for the product Benzocaine (NDC 71888-101). 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, inactive ingredient, dosage & administration, warnings, otc - purpose, indications & usage, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
EthylAlcohol, PEG-8, Purified Water, Carbomer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid
Dosage & Administration
USES: For the temporary relief of discomfort and pain associated with
- minor burns and skin irritations
- minor cuts and scrapes
- itching
DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.
Warnings
For external use only. Avoid contact with the eyes.
Stop use and ask a doctor if:
- Skin becomes irritated
- Condition worsens or symptoms last more than 7 days
- Symptoms clear up and reoccur within a few days
DO NOT USE: in large quantities, particularly over raw surfaces or blistered areas.
Otc - Purpose
Topical Anesthetic
Indications & Usage
USES: For the temporary relief of discomfort and pain associated with
- minor burns and skin irritations
- minor cuts and scrapes
- itching
DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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