AVEENO ACTIVE NATURALS ECZEMA THERAPY ITCH RELIEF BALM- oatmeal cream

Aveeno Active Naturals Eczema Therapy Itch Relief Balm by

Drug Labeling and Warnings

Aveeno Active Naturals Eczema Therapy Itch Relief Balm by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 - 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)

INGREDIENTS AND APPEARANCE

AVEENO ACTIVE NATURALS ECZEMA THERAPY ITCH RELIEF BALM 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y)	Oatmeal	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0035-1	28 g in 1 JAR; Type 0: Not a Combination Product	09/01/2016	11/09/2020
2	NDC: 69968-0035-9	312 g in 1 JAR; Type 0: Not a Combination Product	09/01/2016	02/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	09/01/2016	02/04/2021

Labeler - Johnson & Johnson Consumer Inc. (002347102)