Active Ingredient
Benzocaine 5%
Flocean Anti-itch Cream
FDA Label NDC 85248-094
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Flocean Anti-itch (NDC 85248-094). 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, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Use
temporarily relieves itching
Warnings
For external use only
Do Not Use
if you have a vaginal discharge. Consult a physician.
When Using
Avoid contact with eyes
Stop Use
condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again with in a few days Do not apply over large areas of the body
Ask Doctor
condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again with in a few days Do not apply over large areas of the body
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children 12 years and older apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap.Keep cap tightly closed between uses.
Other Information
children under 12 years consult a doctor
Inactive Ingredients
water 、Glycerol 、Propylene Glycol 、Polydimethylsiloxane 、Trolamine、Borneol、MENTHAPIPERITA、Methylparaben 、Chlorhexidine
Principal Display Panel
5 (954aa42f84b8f09f6288827aa0ca6f99)
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