Shuifulan High-efficiency Anti-bacteria Monomer Silver Gel For Women
FDA Label NDC 69519-0101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shuifulan (beijing) Biological Technology Co., Ltd for the product Shuifulan High-efficiency Anti-bacteria Monomer Silver Gel For Women (NDC 69519-0101). 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, when using, do not use, stop use, ask doctor, ask doctor/pharmacist, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Silver content: 350 μg/g; 4200 μg/package

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.

When Using

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.

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.

Do Not Use

Do not use if allergic to silver.

And it is not for virgins.

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.

Stop Use

Stop use when finding any unpleasant symptoms.

Ask Doctor

Ask doctor before you sure it is safe to your body.

Ask Doctor/Pharmacist

Ask doctor/pharmacist when you current use other drugs.

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.

Questions

Please contact us when you have any questions.

Pregnancy Or Breast Feeding

Pregnant or breast feeding women shall follow doctor advice.

Indications & 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 & Administration

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.

Dosage Forms & Strengths

Dosage form is Gel

Strengths is 3g(3mL)/tube

Warnings And Precautions

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.

Package Label. Principal Display Panel

Container Label

Package Label

Inactive Ingredient

Carbomer 934 content: 6 mg/g; 72 mg/package

Water content: 293650 μg/g; 3523800 μg/package

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