Otc - Active Ingredient
COPTIS CHINENSIS EXTRACT
CANARIUM ALBUM EXTRACT
BORIC ACID
CALENDULA OFFICINALIS EXTRACT
Precilyx Vaginal Probiotics Gel
FDA Label NDC 76986-017
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 Quadrant Ecological Technology Co., Ltd. for the product Precilyx Vaginal Probiotics Gel (NDC 76986-017). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antimicrobial
Indications & Usage
To mitigate symptoms associated with knownbacterial vaginosis infections, such as apungent odor, excessive discharge, as wel!as discomfort and burning during urination.
Warnings
For vaginal use only.
Otc - Do Not Use
Do not use if you have not been diagnosed by a doctor with bacterial vaginosis.
Otc - When Using
Do not use tampons, douches, spermicides, or other vaginal products.
Avoid vaginal intercourse.
This product may damage condoms and diaphragms, making them less effective at preventing pregnancy or sexually transmitted infections (STls)
Minor vaginal buring, itching, or irritation may increase.
Otc - Stop Use
Symptoms do not improve within 3 days.
Symptoms last more than 7 days.
A rash, hives, abdominal pain, fever, chills, nausea, or vomiting occurslrritation becomes severe.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 12 years and older:
1.Thoroughly wash your hands and the external vaginal area.
2.Remove the bottom cover and the top cap.
3.Attach the top cap to the base.
4.Press plunger gently.
5.Lie on your back with your knees bent Gently insert the applicatorinto the vagina and press plunger fully to release the gel.
6.Withdraw and discard the applicator.
7.Use one applicatorful daily, preferably at bedtime
Children under 12 years: Consult a health professional.
Inactive Ingredient
Water, Lactobacillus Ferment Lysate, Huanghuai Extract, Huangshan Extract, Snake SeedExtract, Vaginal Probiotics, Aloe Vera Extract, Qian Jin Teng Extract, Carthamus Tinctorius(Safflower) Extract, Lithospermum Ervthrorhizon Extract, Cocos Nucifera (Coconut) Oil.Tocopheryl Acetate,Squalane, Simmondsia Chinensis (Jojoba) Seed Oil. Carbomer
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Label (Label)
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