NDC Code(s) : 67618-151-04, 67618-151-16, 67618-151-17, 67618-151-32, 67618-151-01
Packager : Atlantis Consumer Healthcare, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Betadine POVIDONE-IODINE SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-151
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE(UNII: 85H0HZU99M)
(IODINE - UNII:9679TC07X4) 		IODINE.075 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIUM NONOXYNOL-4 SULFATE(UNII: 9HIA70O4J0)
NONOXYNOL-9(UNII: 48Q180SH9T)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67618-151-04118 mL in 1 BOTTLE Type 0: Not a Combination Product07/01/1996
2NDC:67618-151-16473 mL in 1 BOTTLE Type 0: Not a Combination Product07/01/1996
3NDC:67618-151-171 in 1 CARTON 07/01/1996
3473 mL in 1 BOTTLE Type 0: Not a Combination Product07/01/1996
4NDC:67618-151-32946 mL in 1 BOTTLE Type 0: Not a Combination Product07/01/1996
5NDC:67618-151-013780 mL in 1 BOTTLE Type 0: Not a Combination Product07/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M003 07/01/1996

LABELER - Atlantis Consumer Healthcare, Inc.(118983925)

REGISTRANT - Atlantis Consumer Healthcare, Inc.(118983925)

PRINCIPAL DISPLAY PANEL

Betadine Surgical Scrub
NDC 67618-151-17

NDC 67618-150-17