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

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

Other Information

Inactive Ingredients

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

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 312 g Jar Label

Aveeno®
baby
NEW
LOOK
Same
Great
Formula
eczema
therapy

nighttime balm

colloidal oatmeal skin
protectant + ceramide

NET WT. 11 OZ (312 g)

Recommended
by Pediatricians &
Dermatologists

clinically proven to
relieve itchy, dry,
irritated skin due
to eczema

fragrance-free
hypoallergenic
steroid-free

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

PRINCIPAL DISPLAY PANEL - 312 g Jar Label
AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0540
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ISOCETYL ALCOHOL (UNII: 1800H64066)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
CERAMIDE NP (UNII: 4370DF050B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
OAT (UNII: Z6J799EAJK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0540-228 g in 1 JAR; Type 0: Not a Combination Product03/25/2019
2NDC:69968-0540-5156 g in 1 JAR; Type 0: Not a Combination Product03/25/2019
3NDC:69968-0540-1312 g in 1 JAR; Type 0: Not a Combination Product03/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/25/2019
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 1/2023
Document Id: eebe1803-1011-1f8f-e053-2a95a90a7266
Set id: 04d90e45-c2ee-4122-b919-a0eb6d11b59a
Version: 5
Effective Time: 20230109
 
Johnson & Johnson Consumer Inc.