AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM- oatmeal cream 
Johnson & Johnson Consumer Inc.

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.

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Aveeno Baby® Eczema Therapy NIGHTTIME BALM

Drug Facts

Active Ingredient

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

  • Temporarily protects and helps relieve minor skin irritation and itching due to:
    • eczema
    • rashes

Warnings

For external use only.

When using this product

  • do not get into eyes.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply as needed.

Other Information

  • Do not use if quality seal is broken or missing.
  • Protect from Excessive Heat (40°C/104°F).

Inactive Ingredients

Glycerin, Water ,Cetearyl Alcohol, Isocetyl Alcohol, Dimethicone, Cetyl Alcohol, Ethylhexylglycerin, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Ceramide NP, Caprylic/Capric Triglyceride, Sodium Cetearyl Sulfate, Potassium Phosphate, Dipotassium Phosphate, Stearic Acid, Sodium Hydroxide, Citric Acid, Benzyl Alcohol, p –Anisic Acid, Benzoic Acid.

Questions or Comments?

Call toll-free 866-4AVEENO (866-428-3366) or 215-273-8755 (collect)

www.aveeno.com

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 312 g Jar Label

Aveeno
Baby®

Eczema
Therapy

NIGHTTIME BALM
colloidal oatmeal . skin protectant cream

Steroid-free . Fragrance-free . Paraben-free .
Phthalate-free . Hypoallergenic
Specially formulated to provide immediate
and long-lasting moisture through the night.

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

PEDIATRICIAN
RECOMMENDED
BRAND

NET WT. 11 OZ (312g)

Principal Display Panel - 312 g Jar Label
AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0369
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Isocetyl Alcohol (UNII: 1800H64066)  
Dimethicone (UNII: 92RU3N3Y1O)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Oat Kernel Oil (UNII: 3UVP41R77R)  
Oat (UNII: Z6J799EAJK)  
Ceramide NP (UNII: 4370DF050B)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Sodium Cetostearyl Sulfate (UNII: 7ZBS06BH4B)  
Potassium Phosphate, Unspecified Form (UNII: B7862WZ632)  
Dibasic Potassium Phosphate (UNII: CI71S98N1Z)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Benzyl Alcohol (UNII: LKG8494WBH)  
p-Anisic Acid (UNII: 4SB6Y7DMM3)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0369-128 g in 1 JAR; Type 0: Not a Combination Product12/01/201702/11/2021
2NDC:69968-0369-2312 g in 1 JAR; Type 0: Not a Combination Product12/01/201701/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34712/01/201702/11/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2019
Document Id: 821fefbc-cc48-4736-9454-b88bf54f1f42
Set id: aab08993-9693-486e-9438-87d12e4d6b36
Version: 2
Effective Time: 20190417
 
Johnson & Johnson Consumer Inc.