APLICARE POVIDONE-IODINE  - povidone-iodine douche 
Aplicare, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

Antiseptic

For temporary relief of minor itching and irritation

Do not use if sensitive to iodine

For vaginal use only

 

Stop use and ask a doctor if


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


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 or comments?

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Povidone-iodine Douche

Povidone-iodine douche

APLICARE POVIDONE-IODINE  
povidone-iodine douche
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1730
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Povidone-iodine10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-1730-260 g in 1 BOTTLE
2NDC:52380-1730-8240 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33309/01/1998
Labeler - Aplicare, Inc. (107255002)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.058377631manufacture

Revised: 4/2010
Document Id: 6780f5fe-51e5-4637-b049-389f557aadb9
Set id: b238d0d5-7e62-4ec6-8de2-84b4754abed2
Version: 1
Effective Time: 20100426
 
Aplicare, Inc.