FDA Label for Recuro Vaginal

View Indications, Usage & Precautions

Recuro Vaginal Product Label

The following document was submitted to the FDA by the labeler of this product Iona Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Drug Facts

Active Ingredient                              Purpose

Povidone-Iodine 0.30%..............Vaginal Douche


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


* Please review the disclaimer below.