AVEENO ACTIVE NATURALS ECZEMA THERAPY ITCH RELIEF 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® Eczema Therapy Long-Lasting Itch Relief 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, 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 or comments?

Call toll-free 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 - 17214

Aveeno®
ACTIVE NATURALS®

Eczema
Therapy

ITCH RELIEF BALM
colloidal oatmeal . skin protectant cream

helps relieve itching due to eczema, rashes,
poison ivy ,oak, sumac and insect bites

non-greasy. steroid-free .safe for daily use

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

DERMATOLOGIST
RECOMMENDED
BRAND

Net Wt. 11 Oz. (312g)

PRINCIPAL DISPLAY PANEL - 312 g Jar Label - 17214

PRINCIPAL DISPLAY PANEL - 312 g Jar Label - 16934

Aveeno®
ACTIVE NATURALS®

Eczema
Therapy

ITCH RELIEF BALM
colloidal oatmeal . skin protectant cream

Immediate itch relief that lasts for eczema
prone skin

non-greasy. steroid-free .safe for daily use

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

DERMATOLOGIST
RECOMMENDED
BRAND

Net Wt. 11 Oz. (312g)

PRINCIPAL DISPLAY PANEL - 312 g Jar Label - 16934
AVEENO ACTIVE NATURALS ECZEMA THERAPY ITCH RELIEF BALM 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0035
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)  
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Dimethicone (UNII: 92RU3N3Y1O)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Sodium Cetostearyl Sulfate (UNII: 7ZBS06BH4B)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
p-Anisic Acid (UNII: 4SB6Y7DMM3)  
Potassium Phosphate, Unspecified Form (UNII: B7862WZ632)  
Oat Kernel Oil (UNII: 3UVP41R77R)  
Ceramide NP (UNII: 4370DF050B)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Oat (UNII: Z6J799EAJK)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0035-128 g in 1 JAR; Type 0: Not a Combination Product09/01/201611/09/2020
2NDC:69968-0035-9312 g in 1 JAR; Type 0: Not a Combination Product09/01/201602/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34709/01/201602/04/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2019
Document Id: 53fa8d93-c84f-4950-98f9-5d5d6500f8ef
Set id: ac76f7b7-2d70-4d3a-85a0-beeabb87db6d
Version: 3
Effective Time: 20190417
 
Johnson & Johnson Consumer Inc.