NDC Code(s) : 52380-2801-8
Packager : Aplicare Products, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aplicare Povidone-IodinePovidone-Iodine SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-2801
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE(UNII: 85H0HZU99M)
(IODINE - UNII:9679TC07X4) 		IODINE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
NONOXYNOL-9(UNII: 48Q180SH9T)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52380-2801-859 mL in 1 BOTTLE Type 0: Not a Combination Product01/01/1998
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 01/01/1998

LABELER - Aplicare Products, LLC(081054904)

REGISTRANT - Medline Industries, LP(025460908)

PRINCIPAL DISPLAY PANEL

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