APLICARE POVIDONE-IODINE- povidone-iodine douche

Aplicare Povidone-iodine by

Drug Labeling and Warnings

Aplicare Povidone-iodine by is a Otc medication manufactured, distributed, or labeled by Aplicare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone-Iodine USP 10% (0.16% when diluted)

PURPOSE

Antiseptic

For temporary relief of minor itching and irritation

WARNINGS

Do not use if sensitive to iodine

For vaginal use only

STOP USE

 

Stop use and ask a doctor if

• symptoms persist for more than 7 days you have pain or tenderness in the lower part of the

  abdomen and pelvis
• you have vaginal discharge or bleeding, chills, nausea, or fever 
• your vaginal discharge is an unusual amount, color or  odor
• you have frequent and painful urination
• douching results in pain, soreness, swelling, redness,  itching, excessive dryness or irritation

ASK DOCTOR

If pregnant or breast-feeding, ask a health professional before use 

DOSAGE & ADMINISTRATION

Use twice weekly unless directed by a physician.  Add 1/2 fluid ounce (one tablespoonful) to 1 quart of lukewarm water.  For other uses consult a physician.

QUESTIONS

Questions or comments?

1 800 760-3236 (M-F 8:30 AM - 5:00 PM EST)

PRINCIPAL DISPLAY PANEL

Povidone-iodine Douche

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE  
povidone-iodine douche

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-1730
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Povidone-iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Povidone-iodine	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Nonoxynol-10 (UNII: K7O76887AP)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Phosphate, Dibasic Anhydrous (UNII: 22ADO53M6F)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1730-2	60 g in 1 BOTTLE
2	NDC: 52380-1730-8	240 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	09/01/1998

Labeler - Aplicare, Inc. (107255002)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare, Inc.		058377631	manufacture