Otc - Active Ingredient
Miconazole Nitrate 2%
Gemachlich Zu Hause Vaginal Antifungal Gel
FDA Label NDC 87681-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Xinhongda Trading Service Co., Ltd. for the product Gemachlich Zu Hause Vaginal Antifungal Gel (NDC 87681-010). 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 known bacterial vaginosis infections, such as a pungent
odor, excessive discharge, as well as discomfort and burning during urination.
Warnings
For vaginal use only.
Otc - Do Not Use
Do not use tampons, douches, spermicides, or other vaginal products.
Avoid vaginal intercourse.
Otc - When Using
Ask a doctor before if you are using other vaginal medicines
This product may damage condoms and diaphragms, making them less effective at preventing pregnancy or sexually transmitted infections (STIs).
Minor vaginal burning, 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 occurs.
Irritation becomes severe.
if you are pregnant or breastfeeding, ask a health professional before use.
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.
Dosage & Administration
ยท For adults use only.
1.Thoroughly wash your hands and theexternal vaginal area.
2.Open the package.
3.Remove the cap from the applicator.
4.Gently push the plunger to releasethe gel.
Inactive Ingredient
WATER
BUTYLENE GLYCOL
METHYLPROPANEDIOL
HYDROXYETHYLCELLULOSE
LACTOBACILLUS FERMENT LYSATE
BIFIDA FERMENT LYSATE
LACTOCOCCUS FERMENT LYSATE
CAMELLIA SINENSIS LEAF EXTRACT
ARTEMISIA PRINCEPS LEAF EXTRACT
CENTELLA ASIATICA EXTRACT
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT
PROPYLENE GLYCOL
HYDROXYACETOPHENONE
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF EXTRACT
TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT
LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT
XANTHAN GUM
ALOE VERA EXTRACT
AVENA SATIVA (OAT) BRAN EXTRACT
HIPPOPHAE RHAMNOIDES FRUIT EXTRACT
CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT
ADENOSINE
SODIUM HYALURONATE
Package Label.Principal Display Panel
Label (Label)
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