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Female Intimate Hygiene Antibacterial Gels
Female Intimate Hygiene Antibacterial Gels
FDA Label NDC 81983-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Mengti Biotechnology Co.ltd for the product Female Intimate Hygiene Antibacterial Gels (NDC 81983-101). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
Benzalkonium bromide 0.10% w/w. Purpose: Antibiotic
Purpose
Antibiotic, Female Intimate Hygiene Antibacterial Gels
Use
for vagina to inhibit Staphylococcus aureus, Escherichia coli and Candida albicans.This product is not a substitute for medicines.
Warnings
For external use only
Disposable, do not reuse it
Do Not Use
- during menstruation, pregnancy, or breastfeeding
Otc - When Using
do not get into eyes
if contact occurs, rinse eyes throughly with water
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Wash hands and clean the vulva
- Remove the front cover of the gel and insert the removed front cover into the rear end of the gel tube as a push rod
- Lie on your back and push the gel into the vagina with the gel pusher
- Take out the gel pusher, and lie still for three minutes.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Sophora Flavescens Root Extract, Averrhoa Carambola Fruit
Extract, Glycine Max (Soybean) Seed Extract, Pyrus Pyrifolia Fruit Extract
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