Otc - Active Ingredient
Drug Facts
Active Ingredient Purpose
Povidone-Iodine 0.30%..............Vaginal Douche
Recuro Vaginal
FDA Label NDC 51670-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Iona Pharmacy for the product Recuro Vaginal (NDC 51670-100). 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 - stop use, otc - pregnancy or breast feeding, 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
Purpose
Vaginal Douche
Indications & Usage
Uses
For relief of minor vaginal irritation and itching
For relief of minor vaginal soreness.
Warnings
Warnings
Ask a doctor before use if you have
Kidney disfunction
Thyroid gland dysfunction
Otc - Do Not Use
Do not use
orally
if you are sensitive to iodine
Otc - Stop Use
Stop use and ask a doctor if
minor irritation has not improved after 1 week of use
symptoms continue or redness, swelling or pain develop
Otc - Pregnancy Or Breast Feeding
If pregnant or breasts feeding, 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
Directions. Use as a douche as needed, except under the advice and supervision of a physician.
Description
Other Information
Store below 98F/37C avoid direct heat and sunlight
Inactive Ingredient
Inactive Ingredientscitric acid, disodium phosphate, water
Package Label.Principal Display Panel
NDC 51670-100-01
This unit not relabeled for retail sale.
Recuro
Vaginal Douche
Liquid Solution
Vaginal Drug Product- For minor irritations
DOES NOT PREVENT PREGNANCY
keep this and all drugs out of the reach of children.
net 0.33 fl oz (10ml)
**do not use if carton is open or damaged.**
To report a serious adverse event contact 1 (703) 646-8867
Expiration date Lot Number
Distributed by Iona Pharmacy LLC
11654 Plaza America Drive Suite 777
Reston, Virginia 20190 USA
Iona Pharmacy LLC
www.iona pharmacy .com
Tel: +1-703-928-8552 Fax: 1-703-773-6921
Manufactured by:
Chuzhou Iris Family Product Co., Ltd.
No. 118, Ze-Wei Southern Road
Chuzhou, Anhui Province, China 239000
Email: [email protected]
Product of China
Recuro Vaginal Douche1 (Iona)
Recuro Vaginal Douche2 (Ionabox)
* Please review the disclaimer below.
