AVEENO BABY ECZEMA THERAPY MOISTURIZING- 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 MOISTURIZING CREAM

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

  • To open, twist off cap and remove quality seal.
  • Do not use if quality seal is broken.
  • For use on mild to moderate eczema or as directed by a physician.
  • Store at room temperature.

Inactive ingredients

water, glycerin, panthenol, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, dimethicone, Avena Sativa (oat) kernel oil, steareth-20, benzalkonium chloride, ceramide NP, sodium chloride, Avena Sativa (oat) kernel extract

Questions?

866-4AVEENO; Outside US, dial collect 215-273-8755 or visit www.aveeno.com

Distributed in the US by:

JOHNSON & JOHNSON
CONSUMER PRODUCTS
COMPANY

Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 206 g Tube Label

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
AVEENO BABY ECZEMA THERAPY MOISTURIZING 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-1404
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-1404-1140 g in 1 TUBE; Type 0: Not a Combination Product06/29/201108/01/2018
2NDC:58232-1404-4206 g in 1 TUBE; Type 0: Not a Combination Product06/29/201108/01/2018
3NDC:58232-1404-214 g in 1 TUBE; Type 0: Not a Combination Product06/29/201108/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/29/201108/01/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 7/2016
 
Johnson & Johnson Consumer Inc.