Active Ingredient
Benzocaine 20% w/v
Outgro Liquid
FDA Label NDC 63029-531
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Outgro (NDC 63029-531). 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, use, warnings, when using this product:, stop use and ask a doctor if:, keep out of the reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Use
For the temporary relief of pain associated with minor skin irritations.
Warnings
■ For external use only.
■ Extremely Flammable. Keep away from fire or flame. Avoid smoking during use and until product has dried.
When Using This Product:
avoid contact with eyes.
Stop Use And Ask A Doctor If:
■ condition worsens ■ condition does not improve in 7 days ■ condition clears up and occurs again within a few days.
Keep Out Of The 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 | Using applicator, apply to affected area not more than 3 to 4 times daily |
| Children under 2 years of age | Consult a doctor |
Other Information
■ store at room temperature away from heat.
Inactive Ingredients
Alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, PEG-8
Questions?
1-800-443-4908
Principal Display Panel
Outgro
BENZOCANE
PAIN RELIEVING
LIQUID
.31 FL OZ/ 9 mL
Outgrobenzocanepain Relievingliquid.31 Fl Oz/ 9 mL (Outgro 01)
* Please review the disclaimer below.
