NDC Code(s) : 58232-1404-1, 58232-1404-4, 58232-1404-2
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aveeno Baby Eczema Therapy MoisturizingOatmeal CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58232-1404
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oatmeal(UNII: 8PI54V663Y)
(Oatmeal - UNII:8PI54V663Y)
Oatmeal10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Glycerin(UNII: PDC6A3C0OX)
Panthenol(UNII: WV9CM0O67Z)
Distearyldimonium chloride(UNII: OM9573ZX3X)
Petrolatum(UNII: 4T6H12BN9U)
Isopropyl Palmitate(UNII: 8CRQ2TH63M)
Cetyl Alcohol(UNII: 936JST6JCN)
Dimethicone(UNII: 92RU3N3Y1O)
Oat Kernel Oil(UNII: 3UVP41R77R)
Steareth-20(UNII: L0Q8IK9E08)
Benzalkonium Chloride(UNII: F5UM2KM3W7)
Ceramide NP(UNII: 4370DF050B)
Sodium Chloride(UNII: 451W47IQ8X)
Oat(UNII: Z6J799EAJK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58232-1404-1140 g in 1 TUBE Type 0: Not a Combination Product29/06/2011
2NDC:58232-1404-4206 g in 1 TUBE Type 0: Not a Combination Product29/06/2011
3NDC:58232-1404-214 g in 1 TUBE Type 0: Not a Combination Product29/06/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 06/29/2011 08/01/2018

PRINCIPAL DISPLAY PANEL

PEDIATRICIAN
RECOMMENDED

Aveeno ®
Baby ®
Eczema
Therapy
MOISTURIZING
CREAM
colloidal oatmeal – skin protectant

Relieves dry, itchy, irritated skin
due to eczema

Clinically shown to soothe babies
with eczema

Steroid-free, fragrance-free

ACCEPTED
nationaleczema.org
National Eczema Association

Net Wt. 7.3 oz. (206g)

Principal Display Panel - 206 g Tube Label