|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Purpose for Benzocaine
- For temporary relief of pain and itching associated with minor burns, sunburn, scrapes and insect bites or minor skin irritations
Keep Out of Reach of Children
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center.
Indications and Usage
- For temporary relief of pain and itching associated with minor burns, sunburn, scrapes and insect bites or minor skin irritations.
- For adults and children 2 years of age and older, apply to affected area not more than 3-4 times daily.
- Children under 2 years; consult a physician.
Stop UseStop use:
- If irritation and redness develop.
- If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.
Storage and Handling
- Avoid excessive heat.
- Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)
|Labeler - Dynarex Corporation (008124539)|
|Registrant - Dynarex Corporation (008124539)|
|Specialty Medical Supplies Beijing Co. Ltd||527931072||manufacture(67777-246)|
Document Id: c458c665-d456-4d16-9fee-e0937c3c3df0
Set id: 6161e94c-7849-466e-8da3-a6f1b085bdf9
Effective Time: 20130204