Active Ingredient
Chlorhexidine acetate 0.15%
Hydrogel Essence Antimicrobial Virginal Gel.
FDA Label NDC 84642-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Amoreneg Medicine Research And Development Co., Ltd for the product Hydrogel Essence Antimicrobial Virginal Gel. (NDC 84642-001). 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, stop use and ask a doctor, if pregnant or nreast-feeding, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Vaginal Antiseptic
Use
Inhibitory microorganisms: Escherichia coli, Staphylococcus aureus, Candida albican
Warnings
■ For vaginal use only;
■ Do not take orally;
■ Avoid co-use with antagonistic drugs;
■ It shall not be used for the prevention of sexually transmitted diseases during sexual life.
Stop Use And Ask A Doctor
if you get a rash or hives, abdominal pain,fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge.
If Pregnant Or Nreast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Aduits and children 12 years of age and over: Thoroughly clean the vulva.Take one tube of the product and remove the cap from the gel applicator. Lie flat on your back. Gently insert the applicator into the vagina and push the hydrogel inside. Remain lying still for 2 minutes to allow the hydrogel to set and transition from liquid to gel format at body temperature.Children under 12 years of age: ask a doctor
Storage
Store the product at room temperature for convenience.
For optimail results, store between 4°C and 20°C
Inactive Ingredients
Chitosan, Poloxamer 407 and Zinc Chloride
Label＆Pack
84642 (84642 001 01)
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