Active Ingredient
Silver content: 350 μg/g; 1050 μg/package
Bang Er Jie High-efficiency Anti-bacteria Monomer Silver Gel For Women
FDA Label NDC 60659-0101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bang An Bao Medical Equipment Co., Ltd. for the product Bang Er Jie High-efficiency Anti-bacteria Monomer Silver Gel For Women (NDC 60659-0101). 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, indcations and usage, dosage, warnings, otc - keep out of reach of children, package label - principal display panel, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Bacteria
Monomer silver gel is a highly active agent which significantly suppresses and eliminates Candida albicans, Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa within and around the vagina, prevents and cures inflammation, accelerates the recovery of wounds and lesioned tissues regardless of vagina pH without affecting normal vaginal bacteria.
Indcations And Usage
Indication to bacterial vaginal diseases; vaginal candida infection; cervicitis; pruritus; abnormal vaginal discharge, or unpleasant smell due to vaginitis.
Topical use: Apply on the affected area of vagina.
Dosage
For bacterial vaginitis and candida infection, 1 package each day, for 7 consecutive days, or longer if serious.
For cervicitis, 1 package each day, for 9 consecutive days, or longer if serious.
Warnings
Contraindications:
1, For external use only.
2, Not for virgins.
3, Do not use if allergic to silver.
4, Pregnant women shall follow doctor advice.
Notes:
1, Pregnant women or women in period avoid application in deep part of vagina
2, Do not use if package is broken; do not use with medicine that contains Vaseline, chlorine, iodine or hydrogen peroxide.
3, This product is for external use only; do not take in. The gel may change in color, which is normal and has no impact on its effects.
4, Keep away from clothes to prevent contamination. Sanitary napkin is recommended to absorb the fluid of gel from vagina.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.
Package Label - Principal Display Panel
Package Label.jpg.
Container Lebel.jpg.
Inactive Ingredient
Carbomer 934 content: 6 mg/g; 18 mg/package
Water content: 293650 μg/g; 880950 μg/package
* Please review the disclaimer below.
