Label: AVEENO BABY ECZEMA THERAPY MOISTURIZING- oatmeal cream
- NDC Code(s): 69968-0699-2
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 9, 2023
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PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label
RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGISTSAveeno ®
babyNEW
LOOK
Same Great
Formulaeczema
therapymoisturizing cream
colloidal oatmeal skin
protectant + vitamin B5
clinically proven to
relieve itchy, irritated
skin due to eczemaACCEPTED
e
NATIONALECZEMA.ORGNATIONAL
Eczema
ASSOCIATIONfragrance-free & steroid-free
hypoallergenic12 FL OZ (354 mL)
30045766
-
INGREDIENTS AND APPEARANCE
AVEENO BABY ECZEMA THERAPY MOISTURIZING
oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0699 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 10 g in 1 mL 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 1 NDC:69968-0699-2 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2010 Labeler - Johnson & Johnson Consumer Inc. (118772437)