Active Ingredient
Povidone-Iodine 0.1% (w/w)
Aibrave Gel
FDA Label NDC 87854-003
9 label sections · Submitted to the FDA by Tupelo Brittany Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tupelo Brittany Llc for the product Aibrave (NDC 87854-003). 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, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic / Antimicrobial
Uses
- Reduce vaginal microorganisms that may cause odor, discomfort, or imbalance.
- Supports a healthy vaginal environment, natural protection, and the body's natural HPV clearance.
- Provides gentle intimate care and temporary relief of mild irritation.
- For intravaginal and external topical use.
Warnings
For external and intravaginal use only
Do not use
- If pregnant or breast-feeding, ask a health professional before use
- on scars, eczema, or dermatitis
- if you have a known allergy to any listed ingredients
- After opening the cap, use the product immediately and do not reuse it
- avoid contact with eyes; if contact occurs, rinse thoroughly with water
- mild temporary tingling may occur
- do not share applicators
- irritation, rash, redness, or discomfort occurs
- abnormal discharge, fever, pelvic pain, or foul odor develops
When using this product
Stop use and ask a doctor if
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control immediately.
Directions
After washing your hands, open the package, remove the cap, and apply it to the intimate area.
Use one applicator once daily; do not use during menstruation.
Discard applicator after one application.
Other Information
- Avoid freezing
- Protect from direct sunlight and excessive heat above 40°C (104°F)
Expiration date / lot number printed on packaging
Inactive Ingredients
Purified Water (Aqua), Glycerin, Carbomer, Propylene Glycol, Butylene Glycol, Triethanolamine, 1,2-Hexanediol, Glyceryl Glucoside, Beta-Glucan of Schizophyllum Commune, Collagen Porcine, Epigallocatechin Gallate, Salvia Miltiorrhiza Root Extract, Curcuma Longa Root Extract, Vitis Vinifera Seed Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Extract, Rheum Tanguticum Root Extract, Scutellaria Baicalensis Extract, Astragalus Membranaceus Mongholicus Extract, Hypericum Perforatum Extract, Centella Asiatica Extract, Arnebia Euchroma Extract, Glycyrrhiza Uralensis (Licorice) Extract.
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