APLICARE POVIDONE-IODINE PERINEAL WASH- povidone-iodine perineal wash liquid

Aplicare Povidone-iodine Perineal Wash by

Drug Labeling and Warnings

Aplicare Povidone-iodine Perineal Wash 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

PURPOSE

Antiseptic

ASK DOCTOR

Stop use and ask a doctor if

• infection occurs
• redness, irritation, swelling or pain persists or increases

Ask a doctor before use if injuries are

• deep puncture wounds
• serious burns
  

DO NOT USE

Do not use if allergic to iodine.

Do not use in eyes.

WARNINGS

Avoid "pooling" beneath patient.  Prolonged exposure to wet solution may cause skin irritation.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

PRINCIPAL DISPLAY PANEL

Bottle Label

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE PERINEAL WASH  
povidone-iodine perineal wash liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-1880
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1880-8	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