NDC Code(s) : 11523-1314-2, 11523-1314-3, 11523-1314-1
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

A and DDimethicone and Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-1314
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE11.09 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE110.09 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
ALOE VERA FLOWER(UNII: 575DY8C1ER)
BENZYL ALCOHOL(UNII: LKG8494WBH)
COCONUT OIL(UNII: Q9L0O73W7L)
COD LIVER OIL(UNII: BBL281NWFG)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
PARAFFIN(UNII: I9O0E3H2ZE)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (White cream) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11523-1314-21 in 1 CARTON 25/12/2009
1113 g in 1 TUBE Type 0: Not a Combination Product
2NDC:11523-1314-31 in 1 CARTON 25/12/2009
285 g in 1 TUBE Type 0: Not a Combination Product
3NDC:11523-1314-11 in 1 CARTON 25/12/2009
342.5 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 12/25/2009

LABELER - Bayer HealthCare LLC.(112117283)

PRINCIPAL DISPLAY PANEL

New Look

A+D ®

Treat

Diaper Rash Cream

with Dimethicone and Zinc Oxide

  • Works on contact to help treat & calm diaper rash
  • Allows skin to heal naturally

PEDIATRICIAN RECOMMENDED

PARABEN-FREE

DYE-FREE

MOISTURIZING WITH ALOE

NET WT

1.5 OZ (42.5 G)

Carton 1.5 oz.