AVEENO ACTIVE NATURALS ECZEMA THERAPY MOISTURIZING- oatmeal lotion 
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® ACTIVE NATURALS® Eczema Therapy MOISTURIZING CREAM
Formula # 11336-165

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

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

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

DERMATOLOGIST
RECOMMENDED

Aveeno®
ACTIVE NATURALS®

Eczema
Therapy
MOISTURIZING CREAM
colloidal oatmeal • skin protectant

Relieves dry, itchy, irritated skin due to eczema

Clinically shown to soothe skin with eczema

Steroid-free, fragrance-free

ACCEPTED
e
NATIONALECZEMA.ORG
NATIONAL
ECZEMA
ASSOCIATION

12 fl. oz. (354 mL)

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label
AVEENO ACTIVE NATURALS ECZEMA THERAPY MOISTURIZING 
oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0377
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal10 mg  in 1 mL
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:69968-0377-1354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/201801/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/01/201801/03/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2020
Document Id: b516a3d3-851a-4be1-af8c-e302a40bdd5c
Set id: a35c905f-8804-47cb-a65c-9038ef1a6e40
Version: 2
Effective Time: 20201013
 
Johnson & Johnson Consumer Inc.